2012-04-17 14:33:21
WorldCare Clinical Appoints New Executive Director of Quality & Regulatory Affairs
2012-03-13 16:12:15
WorldCare Clinical Introduces New 24-Hour Turnaround Services for Imaging Safety Reviews
2012-02-27 16:32:29
2012-02-13 01:35:34
2011-09-20 06:00:33
2011-04-25 16:26:36
WorldCare Clinical Sponsors Evolution Summit 2011 for Leading Drug Development Executives
2010-12-06 20:19:17
WorldCare Clinical Appoints New Associate Director of Quantification and 3D Imaging
2009-06-22 20:31:12
WCC Implements MCC’s Imaging Performance Metrics in Support of Standardized Performance for Trials
2009-04-13 20:38:53
WCC Grows Executive Team with Appointment of New Associate Director of Imaging Services
2009-03-02 20:41:40
WorldCare Clinical Introduces New Collect, Ready, Hold Service for Early-Stage and Phase II Trials
2009-02-26 20:57:26
WorldCare Clinical to Exhibit at CBI’s 6th Annual Medical Imaging for Clinical Trials
2009-01-26 20:58:03
WorldCare Clinical to Exhibit at IIR's 7th Annual Partnering with Central Labs, ECG and Imaging Labs
2009-01-12 21:21:18
WorldCare Clinical Appoints Industry Veteran Richard Walovitch as Chief Medical Officer
2008-11-17 21:21:42
WCC Strengthens Executive Management Team with New Regulatory Affairs and Associate Medical Director
2007-10-26 22:16:21
2007-09-17 21:46:49
WCC Introduces WorldPro Technology Platform for Maximizing the Efficiency of Clinical Trial Imaging
2007-04-23 21:56:40
WorldCare Clinical Forms Partnership with University of Chicago to Expand Image Reading Services
2007-04-10 21:59:57
Breaking News – April 18, 2012
WorldCare Clinical Names Kenneth O’Brien Executive Director of Quality & Regulatory Affairs.
The Calendar – PharmaVOICE April 2012
Imaging in Clinical Trials – Removing Bias and Increasing Precision and Accuracy. Holiday Inn Boston at Beacon Hill, Boston. WorldCare Clinical in conjunction with the Massachusetts General Hospital (MGH) Department of Radiology. http://www.wcclinical.com/the-knowledge-center/in-the-news/wcc-conference/
What’s New – PharmaVOICE April 2012
In response to FDA guidance and growing requests from other regulatory agencies that place new emphasis on assessing and minimizing cardiovascular risk, WorldCare Clinical has added a service offering that supports expert readers in a timely and transparent manner to complete cardiovascular endpoint committee reviews quickly and cost-effectively.
WorldCare Clinical Organizes Conference on Imaging in Trials – Health Imaging Hub
WorldCare Clinical, LLC (WCC), a leading medical imaging CRO concentrating on making medical imaging in trials more precise, announced recently that it will organize a conference on “Imaging in Clinical Trials – Removing Bias and Increasing Precision and Accuracy”.
WorldCare Clinical Establishes CV Endpoint Committees – Applied Clinical Trials
WorldCare Clinical Expands Capabilities with Introduction of New Service Offering for Cardiovascular Endpoint Committees.
“Enrollment: More Than Numbers” – new article in February 2012 issue of Applied Clinical Trials
WCC President Richard Walovitch, PhD, Associate Director of Biostatistics and Data Management Vincent J. Girardi III and Director of Regulatory Affairs John Tomera, PhD, discuss how partnering with CROs and using a blinded independent central review can increase trial success.
“Picture of Perfection” – new article in Autumn 2011 issue of International Clinical Trials
WCC Executive Vice President, Business Development Richard Taranto and President Richard Walovitch, PhD provide an insight into imaging CROs in central and eastern Europe, including guidelines and best practices for standardization of imaging equipment for clinical trials.
“Faster Alzheimer’s detection in sight” – WCC’s Dr. Richard Walovitch featured in September R&D Directions
September 2011
by Ed Silverman
WCC President Dr. Richard Walovitch, along with thought leaders from Drexel University, Merck & Co. and Icon Medical Imaging, share their thoughts on how the approval of imaging agents can enable earlier diagnosis of Alzheimer’s disease and potentially pave way to better therapies in a feature on “Solutions for Clinical Trial Imaging – Central Nervous System” in the September 2011 issue of R&D Directions (pg 42-43). In his discussion, Walovitch specifically shares his viewpoints on the value that imaging biomarkers can play in detecting the risk of Alzheimer’s and other forms of dementia at the preclincial stage, when drug therapies have the potential to be most effective. (Subscription required)
“Improving Outcomes in Late-Stage Trials with Independent Reviews” – featured in Applied Clinical Trials, September 2011
September 2011
WCC Executive Vice President, Business Development Richard Taranto and President Richard Walovitch, PhD, discuss how outcomes in late-stage trials can be improved with a
blinded independent central review (BICR).
“Imaging CROs in Asia”
April 2011
WCC Executive Vice President, Business Development Richard Taranto and President Richard Walovitch, PhD, discuss considerations for oncology trials in Asia, including the value of reader variability training and testing.
“Applied Clinical Trials’ Business and News Update”
February 1, 2011
by Kayda Norman
WorldCare Clinical (Boston, MA) has promoted Richard Walovitch, PhD, from Chief Medical Officer to President, and Xiaozhou Ma, MD, has joined as Associate Director of Quantification and 3D Imaging.
“DICOM Izer Eases Digital Film Conversion”
December 13, 2010
WCC Director of Software Engineering Patrick Chokron talks about digitizing films in RT Image using ETIAM’s DICOM Izer. The device, which scans, formats and archives images to prepare them for interpretation, allows images to remain completely anonymous by masking any patient identification before sending them to WCC’s PACS for use by reading radiologists.
“Clinical Trials of the Future”
May 2010
WCC Director of Regulatory Affairs Dr. John F Tomera explains the impact that portfolio management, adaptive design, scheduled interim analysis, and clinical imaging CROs can have on clinical trials in the May 2010 issue of International Clinical Trials (pg. 48-52).
“A Team Approach”
May 2010
WCC Chief Medical Officer Dr. Richard Walovitch and Director of Regulatory Affairs Dr. John F. Tomera explore how independent endpoint assessment committees can overcome imaging limitations in oncology trials in the May 2010 issue of Applied Clinical Trials (pg 18-22). Featured in the “Oncology & Clinical Trials in the 21st Century” supplement, Drs. Walovitch and Tomera discuss the importance of blinding patient data and implementing a streamlined technical approach to effectively demonstrate efficacy via tumor assessment endpoints.
“Adjudication in Oncology Trials: A Concept Whose Time Has Come”
December 2009
WCC Chief Medical Officer Dr. Richard Walovitch joins Director of Biostatistics and Data Management Asli Memisoglu and Associate Director of Clinical Operations Denise Walsh for an overview of clinical imaging endpoints and the regulatory requirements surrounding them in the inaugural issue of PharmaNet Development Group’s FOCUS newsletter. The group makes the case for the use of adjudication in oncology trials specifically, highlighting the importance of independent endpoint assessment committees and the necessary considerations for readying data for the FDA.
“Contract Research Organizations: Radiology’s Newest Revenue Stream”
September 10, 2009
by Julie Ritzer Ross
WCC Chief Medical Officer Dr. Richard Walovitch and Vice President of Business Development Rick Taranto examine the growth of the imaging CRO and what it means for radiology in the August/September 2009 issue of Radiology Business Journal. In a discussion of the trends toward imaging in clinical trials, Dr. Walovitch and Taranto elaborate on WCC’s approach to improving reader reproducibility and the growing importance of volumetric analysis with advanced modalities.
“Metrics and Trial Management”
August 2009
WCC Chief Medical Officer Dr. Richard Walovitch and Director of Biostatistics and Data Management Asli Memisoglu explore the ins and outs of imaging study start-up, including the implementation of standardized performance metrics, in the August 2009 issue of International Clinical Trials (pg 46-50). In their explanation of the benefits of working with an imaging CRO, Dr. Walovitch and Memisoglu emphasize the importance of metrics to overall trial management and success.
“Clinical Trial Imaging: Innovations, Trends and Challenges”
June 2009
by Kristin Brooks
WCC Chief Medical Officer Dr. Richard Walovitch and Vice President of Business Development Rick Taranto join the director of imaging at Charles River Laboratories to address the latest innovations, industry trends, and challenges in clinical trial imaging from the CRO/provider perspective in the June 2009 issue of Contract Pharma.
“3 WorldCare Hires”
May 11, 2009
by Suz Redfearn
“WorldCare Clinical is on a hiring binge. The imaging-focused contract research organization (CRO), which was spun off from Massachusetts General Hospital 17 years ago, has hired three top-level executives in the last five months.”
“Image Boost”
May 2009
by Lyle D. Fitzsimmons
WCC Chief Medical Officer Dr. Richard Walovitch discusses the value of imaging to earlier and more effective go/no-go decisions in the drug development process in a feature on “Solutions for Clinical Trial Imaging” in the May 2009 edition of R&D Directions (pg 32-34). In a discussion of the advances of molecular imaging and its impact on R&D, Dr. Walovitch joins fellow scientists from around the clinical trial imaging world. (Subscription required)
“CRO Trends & Drivers: Specialty Pharma & Biotech Driving Current CRO Growth and Trends”
April 2009
by Cindy H. Dubin
WCC Chief Medical Officer Dr. Richard Walovitch joins executives from Charles River, Quanticate, and Biopharmaceutical Research Inc. for an industry roundtable in Specialty Pharma‘s feature inside Drug Delivery Technology‘s April 2009 issue (pg 64-68). Addressing several CRO industry trends identified by Frost & Sullivan, Dr. Walovitch discusses the movement toward growing sponsor engagement and integration with CROs, particularly in IT system decision-making and management, and earlier-stage studies.
“Walovitch Pictures Growth Potential at WorldCare”
March 13, 2009
by Amber Gay
“As an author and a scientist, Richard Walovitch has been trying to find ways to give back to the industry he has been involved in for more than 20 years. He has now taken that expertise in preclinical and clinical development into the position of chief medical officer at WorldCare Clinical LLC.”
“WorldCare Enhances System”
March 10, 2009
by Suz Redfearn
“Imaging for clinical trials is a hot area, and getting hotter. WorldCare Clinical is beefing up its image management system and tapping its access to top radiologists in the U.S. and less expensive locales.”
“WorldCare Launches Imaging Tech Service”
March 3, 2009
by Maureen Martino
“Imaging CRO WorldCare Clinical has launched a service that allows imaging data to be collected, standardized according to the imaging protocol, and held in a database until a central review is requested. The service – called Collect, Ready, Hold – uses the Boston-based company’s WorldPro image management tech to acquire and prepare imaging data.”
“CROs in Front: Long-Term Investment”
September 2008
by Michael Christel
WCC President Rick Taranto lends his outsourcing industry experience to the annual CRO industry report in the September 2008 issue of R&D Directions (pg 20-27). As the contributing expert on the role of specialty imaging CROs to the drug development process, Mr. Taranto highlights the growing trend among sponsors toward earlier engagement with imaging partners. (Subscription required)
“Clinical Use of Imaging Biomarkers: How to Improve the Efficiency of Clinical Development”
June 2008
ProScan CEO and WCC Chief Medical Officer Dr. Stephen Pomeranz discusses validating biomarkers as surrogate endpoints in clinical trials in Contract Pharma‘s annual June DIA issue (pg 100-103). In his look at the progress of biomarker utilization and regulatory acceptance since the FDA’s Critical Path launch, Dr. Pomeranz calls out the requirements for using imaging in clinical trials and highlights its value with a sample study using cardiac multi-slice CT to test the effectiveness of a potential treatment for cardiovascular disease.
“Latest Imaging Technology a Good Fit for New Therapies”
May 2008
ProScan CEO and WCC Chief Medical Officer Dr. Stephen Pomeranz and ProScan research assistant Dr. Resham Mendi introduce the Dynamic contrast-enhanced MRI procedure and discuss its acquisition during clinical trials in the May 2008 issue of Applied Clinical Trials (pg 10-12). As part of a supplement on “Oncology and Clinical Trials in the 21st Century,” Dr. Pomeranz and Dr. Mendi review the considerations for conducting DCE-MRI studies in oncology trials and for properly planning imaging protocol to address them.
“Screen Door is Wide Open”
April 2008
by Michael Christel
WCC President Rick Taranto, along with executives from Wyeth, Merck, Parexel and Caliper Life Sciences, shares his thoughts on the value of imaging biomarkers to the early stages of the drug discovery process in the “Biomarkers: Expanding Their Discovery” special section in the April 2008 issue of R&D Directions (pg 16-32). In his discussion, Taranto specifically highlights WCC’s use of DCE-MRI biomarkers in cancer trials in collaboration with MGH. (Subscription required)
“Imaging Sites and Clinical Trial Harmony”
October 2007
WCC Director of Clinical Operations Christina Mastandrea reviews the necessary steps for coordinating multisite imaging trials in the the October 2007 issue of Applied Clinical Trials. In her site harmonization overview, Mastandrea emphasizes the importance of standardizing image acquisition protocol, and delineates the most effective ways to minimize the troublesome variances at each stage of a trial.
“A Review of Optical Coherence Tomography in Cardiovascular Research“
September 2007
WCC radiologist Dr. Jim Homsy reviews a new medical imaging text focusing on OCT in the September 2007 issue of Good Clinical Practice Journal (pg 40). Providing a thorough content summary and evaluation, Dr. Homsy sheds new light on a hot topic and recommends the work to physicians who regularly deal with atherosclerosis.
“The PharmaVOICE 100″
July/August 2007
ProScan CEO and WCC Chief Medical Officer Dr. Stephen Pomeranz is named one of the 100 Most Inspiring People in the life sciences industry in the special July/August 2007 issue of PharmaVOICE (pg 46-47). Recognized as a “Risk Taker,” Dr. Pomeranz is profiled as “an inspiration to those in the field of medical imaging.”
“Imaging CROs & Their Impact on Clinical Trials”
June 2007
WCC President Rick Taranto identifies the critical qualities to consider when choosing a central imaging CRO in Specialty Pharma’s cover story inside Drug Delivery Technology’s June 2007 issue (pg 72-76). In sharing his management expertise and practical industry knowledge, Taranto addresses the importance of imaging CROs to specialty pharmas and the impact they can have on clinical trials.
“Imaging in Clinical Trials”
May 2007
WCC President Rick Taranto provides a thoughtful overview of managing imaging for clinical trials in Contract Pharma’s May 2007 “CRO Industry Update” (pg 44). In his discussion of the administrative concerns for imaging CROs during clinical trials, Taranto reviews the necessary steps for handling image acquisition and organization from multiple sites.
“Cincinnati’s Top Doctors”
April 2007
ProScan CEO and WCC Chief Medical Officer Dr. Stephen Pomeranz is named one of the best doctors in the Greater Cincinnati area by his peers in the April 2007 issue of Cincinnati Magazine, accompanied by 14 of his contemporaries within the radiology specialty.
“WorldCare Clinical in Expansionist Mode”
March 23, 2007
by Deborah Borfitz
“With its acquisition by Cincinnati-based ProScan Imaging in mid-2006, WorldCare Clinical (WCC) gained new radiological expertise in more than 20 subspecialty and “super subspecialty” areas that is available “on a moment’s notice” during clinical trials. The buyout also gave WCC the wherewithal to expand geographically beyond its headquarters near Massachusetts General Hospital (MGH) in Cambridge.”
“Imaging is Everything”
February 2007
ProScan CEO and WCC Chief Medical Officer Dr. Stephen Pomeranz and ProScan lead technologist Jeff Bryant compare imaging vendors and equipment for clinical trials in the February 2007 issue of R&D Directions (pg 12-14). In their evaluation of the strengths and weaknesses of the MRI, CT and PET product lines of five major industry vendors, Dr. Pomeranz and Bryant provide an interesting and informative look at the technological options for trial sponsors.
“Imaging on Trial: MRI Versus CT”
January 2007
ProScan CEO and WCC Chief Medical Officer Dr. Stephen Pomeranz and WCC President Rick Taranto discuss the pros and cons of the MRI and CT modalities for clinical researchers when developing trials in the January 2007 issue of Good Clinical Practice Journal (pg 22-25). Exploring the differences in scanner technology, the suitability to anatomical region, and the primary safety considerations of each, Dr. Pomeranz and Taranto lend their technical knowledge and hands-on experience to the science of clinical research.
“Clinical Imaging: The Key to Reducing Drug Development Costs”
November/December 2006
WCC President Rick Taranto makes the case for the value of clinical imaging in PharmaVOICE’s 2007 annual “Year in Preview” issue (pg 36). As a featured thought leader, Taranto explains how the use of imaging biomarkers in pharmaceutical testing can help speed data availability, increase investigative efficiency, and subsequently reduce costs over the course of the drug-development process.
2012-04-17 21:16:33
2012-04-17 14:33:21
WorldCare Clinical Appoints New Executive Director of Quality & Regulatory Affairs
2012-03-13 16:12:15
WorldCare Clinical Introduces New 24-Hour Turnaround Services for Imaging Safety Reviews
2012-02-27 16:32:29
2012-02-14 17:49:53
WorldCare Clinical Establishes CV Endpoint Committees - Applied Clinical Trials
2012-02-13 01:35:34
2012-02-01 16:39:13
"Enrollment: More Than Numbers" - new article in February 2012 issue of Applied Clinical Trials
2011-09-21 23:32:20
2011-09-21 05:01:53
2011-08-29 21:41:15
2011-08-19 18:47:33
Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability
2011-07-17 17:11:52
Two Studies Advance Global Standardization of Biomarkers for Alzheimer's Disease
2011-07-12 23:21:35
2011-06-08 20:48:44
Glowing Cornell Dots – a Potential Cancer Diagnostic Tool Set for Human Trials
2011-05-17 18:47:08
Halving the radiation dose in cardiac perfusion imaging is now 'feasible'
2011-04-25 17:16:18
MBI is an effective adjunct to mammo in women with dense breasts: study
2011-04-22 17:25:53
2011-01-13 17:32:01
Coming of Age For The Biomarker Industry? 4 Key Challenges For Biomarker Companies
2011-01-03 04:04:46
Juventas Therapeutics to Begin Phase 2 Trial for Critical Limb Ischemia
2010-12-27 17:45:39
Elan Pays Transition $9M in Amended Deal for Phase II Alzheimer Candidate
2010-11-18 16:29:06
Paul Allen Donates $9M for Edgy Neuroscience, Biotech Projects at MIT, Stanford, UW
April 22, 2011
Artifact
In medical imaging, artifacts are misrepresentations of tissue structures that appear as blemishes on the image and which may cause image misinterpretation. Caused by motion during the scan acquisition, a patient’s internal metal implants, equipment malfunction, metal fragments, or tiny electrical or radio frequencies, artifact appearance ranges from general blurriness or distortion of a specific piece, to the emergence of faint halos or rings on the image.
Biomarker
Biomarkers are physical, biochemical, or molecular traits used to determine the occurrence or progression of specific disease states or conditions.
BLA
Biologic License Application
Bone Scan
A bone scan is used to detect fractures, cracks, tumors, infections, or other abnormal bone activity. During a bonescan, a radio-labeled substance is injected into the vein and is attracted to areas of high bone metabolic activity.
Cardiac Score
The cardiac score calculates a patient’s risk for heart disease by using a CT scanner to measure the percentage of calcium in the heart’s arteries.
Case Received Notification Fax
As part of WCC’s study documentation, the CRN indicates the WCC’s receipt of imaging data and lists any outstanding queries that must be resolved by the study contact person. If any action is required, the site will provide a documented response and send the CRN back to WCC.
CFR Part 11
CFR Part 11 refers to an FDA mandate that allows electronic record-keeping, provided that the company meets certain requirements created to guarantee the safety and reliability of electronic records and signatures.
CHESON
Named after a founding physician, the CHESON principles are guidelines for assessing clinical response in Non-Hodgkin's Lymphoma (NHL).
Closed Bore
A closed bore (also known as a circumferential unit) is a type of MRI scanner in which a large horizontal tube, open at both ends, surrounds the patient.
Coil
In an MRI machine, the coil is placed at the body part being imaged, where it emits the radiofrequency that forms the image. Coils are made for shoulders, knees and various other body parts.
CT Scan
CT, or computed tomography, shows cross-sections of body tissues and organs. It uses special x-ray equipment to obtain images of the body from a variety of different angles. It is also called computed axial tomography, or CAT.
Detector Coil
The detector coil, or radiofrequency coil, refers to one or more of the loops of the conductor used to generate the magnetic field in an MRI machine.
DEXA
DEXA, or dual energy X-ray absorptiometry, measures bone mineral density using X-ray technology. DEXA is commonly called a bone density scan and is used as a diagnostic test for osteoporosis.
DICOM
DICOM, or Digital Imaging and Communications in Medicine, is a set of standards for storing and exchanging medical images (i.e. the establishment of connection and contact procedures).
Diffusion MRI
One of the newest forms of neuroimaging, a diffusion MRI is a specific MRI modality that uses diffusion weighted imaging to measure the diffusion of water molecules in biological tissues (and subsequently detect early stroke).
Echocardiogram
An echocardiogram uses ultrasound technology—sound-waves—to create two-and three-dimensional images of the heart.
Endpoint
The endpoint is the outcome measured by a clinical trial.
Fluorodeoxyglucose
Fluorodeoxyglucose, or FDG (full chemical name 2-fluoro-2-deoxy-D-glucose), is the glucose analog most commonly used in a PET, where its fluorine molecule (fluorine-18) acts as the radioactive isotope and is injected into the patient. A PET scanner then forms images of the isotope's distribution throughout the body, and said images are interpreted by a nuclear medicine physician or radiologist to aid in diagnosis.
Functional Magnetic Resonance Imaging
Functional Magnetic Resonance Imaging (fMRI) measures the hemodynamic response to neural activity in the brain or spinal cord through the use of MRI.
GCP
GCP, or Good Clinical Practice, is an international quality standard for designing, managing, documenting, analyzing and reporting clinical studies to ensure the accuracy of the resulting data and protection of all subjects’ rights.
Gradient Magnet
The MRI machine’s gradient magnets enable the spotlighting of a specific part of the body. They are also responsible for the clanging noise commonly heard in an MRI.
Gradient Strength
Critical to the MRI system, the performance of the magnetic field’s gradient coils determines the speed and resolution of imaging. Gradients are measured by their maximum strength, or "peak" amplitude, and their rise time (the time needed to reach the maximum amplitude). The gradient amplitudes of today’s clinical systems range from 10 milliTesla per meter (mT/m) up to 40 mT/m. Gradient rise times reach about 1.0 msecond.
Hardware Configuration and Image Transfer Study
The Hardware Configuration and Image Transfer Study establishes the contact information, equipment details, and transfer capabilities (https, MOD, CD or film) of proposed imaging facilities for a particular study. The survey must be completed by all satellite sites prior to their approval by WCC.
Image Acquisition Protocol
The Image Acquisition Protocol, or IAP, provides the details of the study-specific imaging for the specified clinical trial as part of the Radiology Image Preparation & Submission Guide in WCC’s site start-up package.
Image Resolution
An image’s resolution denotes the detail it holds; higher resolution yields greater image detail.
Image Transferal Form
As part of WCC’s site start-up package and study documentation, an Image Transferal Form (ITF) must be completed by each imaging site and sent to WCC with each subject’s imaging data.
IND
An IND is also known as an Investigational New Drug Application.
Independent Imaging Review Charter
Prepared by the Project Manager, Lead Radiologist and Independent Assessment Panel, the Imaging Charter documents the processes in place for deviations from imaging protocol, the receipt and initial quality assessment of imaging, the formatting and submission to independent review, the blinding and labeling of images, actual independent review in detail and response criteria, and the archiving and storage of images, and records these results to be submitted to the FDA.
MRI
MRI, or magnetic resonance imaging, uses a combination of low-frequency radio signals and magnetic fields to acquire two- and three-dimensional body images. It is best suited for examination of soft tissue.
NDA
An NDA is more commonly known as a New Drug Application.
Nuclear Magnetic Resonance Spectroscopy
Nuclear Magnetic Resonance Spectroscopy, most commonly known as NMR Spectroscopy, is an imaging technique which utilizes the magnetic properties of nuclei, most notably proton NMR and carbon-13 NMR.
Oncology Endpoint
Oncology endpoints are endpoints based on tumor assessment. They include disease-free survival, objective response rate, time to progression, and progression-free survival. Recent FDA research has seen the emergence of objective response rate (ORR) and progression-free survival (PFS), both of which are based on radiological endpoints, as the most popular.
Oncology Response Criteria
Oncologists use measurement of response as indicators of the effectiveness of specific therapies in treating cancer. Objective tumor response, for instance, is often used in clinical trials to assess the performance of preventative treatments.
Open Bore
An open bore (also known as an open unit) is a type of MRI scanner which is open on all sides and does not surround the patient.
ORR
An ORR, or Objective Response Rate, is an endpoint for tumor evaluation determined by a discernible and calculable response to treatment (i.e., a decrease in tumor size) over a set time period. The ORR is directly attributed to the drug’s effect and can be measured in single-arm studies.
PACS
PACS, or the Picture Archive Communication System, electronically stores, transmits and displays digital images and other data. This system allows for information management and image viewing at various locations (diagnostic, consultation, etc.)
Pathology Transferal Form
As part of WCC’s site start-up package and study documentation, a Pathology Transferal Form (PTF) must be completed by each imaging site and sent to WCC with each subject’s pathology sample.
Pathology/Image Preparation and Submission Guidelines
These are guidelines for investigative sites on preparing, obtaining and sending all pathology samples and imaging studies to WCC per protocol.
PET
PET, or positron emissions tomography, is a nuclear imaging technique that uses a short-lived radioactive tracer that attaches to the specific area being examined, producing a three-dimensional image of the area.
PFS
Progression – free survival (PFS) is a tumor evaluation endpoint used to determine the effectiveness of a particular treatment by calculating the likelihood of survival without disease progression. PFS usually reflects tumor growth or shrinkage and is independent of the influence of later therapy.
Pixel
Short for "picture element,” the pixel is the smallest unit of an image. Pixel volume determines resolution detail: the more pixels in the picture, the greater the detail.
Primary magnet
The largest part of the MRI machine is the primary magnet, which maintains the strength of the magnetic field necessary for image creation.
Radiology Review Guidelines
As part of the WCC’s Project Management documentation, Radiology Review Guidelines detail response criteria, review process and training for the duration of the study.
RECIST
Response Evaluation Criteria in Solid Tumors Group (RECIST) has developed guidelines of the same name for reviewing cross-sectional imaging studies.
Signal to Noise Ratio
The ratio of the mean pixel value to the standard deviation of the pixel values, an image's Signal to Noise Ratio (SNR) is important to image processing.
Slew Rate
Slew rate is the measurement of gradient strength. The ratio of the maximum gradient strength to the rise time (see “Gradient Strength”), the slew rate provides a means of comparison between gradient systems: the higher the slew rate, the more expensive the gradient system (and, by extension, the MRI machine). Today’s slew rates usually fall between 50 Tesla/second and 150 Tesla/second.
SPA
SPA refers to the Special Protocol Assessment.
Spatial Resolution
Spatial resolution refers to the ability to distinguish two structures at an arbitrarily small distance from one another as separate.
SPECT
SPECT, or single photon emission computed tomography, is a nuclear imaging technique that uses gamma rays to provide two-dimensional, cross-sectional images.
Spectroscopy
Spectroscopy is the study of matter by investigating the light, sound, or particles that a specific matter emits, absorbs or scatters.
Surrogate Endpoint
A finding or measurement used to determine a particular therapy’s safety or efficacy in clinical trials, a surrogate endpoint may be assessed more quickly than traditional endpoints.
Teleradiology
Teleradiology is the electronic exchange of radiological images between different locations for analysis via satellite, LANs, or telephone lines
Tesla
All Magnetic Resonance Imaging machines (MRI) are calibrated in the "Tesla Unit," the international unit of magnetic flux density, measured as one weber per square unit, and named after the founder of the Rotating Magnetic Field, Nikola Tesla. MRI technology is based on this principle of the homogenous magnetic field, and because of its widespread use, will continue to further Tesla’s name.
Tractography
Tractography uses special MRI techniques and electronic post-processing to create two- and three-dimensional images of the neural tracts.
Ultrasound
Also known as a sonogram, an ultrasound image is created using sound waves at a frequency that humans are unable to hear.
Voxel
The smallest unit of volume in a three-dimensional image, the voxel is the 3-D equivalent of the pixel.
WHO
WHO refers to World Health Organization criteria.
X-Ray
X-ray technology uses electromagnetic radiation to identify diseases of the skeletal system and some soft tissues. It is commonly used to identify abnormalities of the lungs and abdomen, such as lung cancer, pneumonia, kidney stones, gallstones, or intestinal blockages.
© 2012 WorldCare Clinical
