Common Terminology for Imaging & Clinical Trials1. 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. 2. Biomarker Biomarkers are physical, biochemical, or molecular traits used to determine the occurrence or progression of specific disease states or conditions. 3. BLA Biologic License Application 4. 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. 5. 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. 6. 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. 7. 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. 8. CHESON Named after a founding physician, the CHESON principles are guidelines for assessing clinical response in Non-Hodgkin's Lymphoma (NHL). 9. 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. 10. 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. 11. 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. 12. 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. 13. 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. 14. 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). 15. 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). 16. Echocardiogram An echocardiogram uses ultrasound technology—sound-waves—to create two-and three-dimensional images of the heart. 17. Endpoint The endpoint is the outcome measured by a clinical trial. 18. 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. 19. 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. 20. 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. 21. 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. 22. 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. 23. 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. 24. 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. 25. Image Resolution An image’s resolution denotes the detail it holds; higher resolution yields greater image detail. 26. 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. 27. IND An IND is also known as an Investigational New Drug Application. 28. 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. 29. 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. 30. NDA An NDA is more commonly known as a New Drug Application. 31. 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. 32. 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. 33. 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. 34. 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. 35. 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. 36. 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.) 37. 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. 38. 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. 39. 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. 40. 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. 41. 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. 42. 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. 43. 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. 44. RECIST Response Evaluation Criteria in Solid Tumors Group (RECIST) has developed guidelines of the same name for reviewing cross-sectional imaging studies. 45. 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. 46. 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. 47. SPA SPA refers to the Special Protocol Assessment. 48. Spatial Resolution Spatial resolution refers to the ability to distinguish two structures at an arbitrarily small distance from one another as separate. 49. SPECT SPECT, or single photon emission computed tomography, is a nuclear imaging technique that uses gamma rays to provide two-dimensional, cross-sectional images. 50. Spectroscopy Spectroscopy is the study of matter by investigating the light, sound, or particles that a specific matter emits, absorbs or scatters. 51. 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. 52. Teleradiology Teleradiology is the electronic exchange of radiological images between different locations for analysis via satellite, LANs, or telephone lines 53. 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. 54. Tractography Tractography uses special MRI techniques and electronic post-processing to create two- and three-dimensional images of the neural tracts. 55. Ultrasound Also known as a sonogram, an ultrasound image is created using sound waves at a frequency that humans are unable to hear. 56. Voxel The smallest unit of volume in a three-dimensional image, the voxel is the 3-D equivalent of the pixel. 57. WHO WHO refers to World Health Organization criteria. 58. 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. |
