Discovery of a Potential Abnormality During a Research Scan
On occasion, a potential abnormality will be discovered during a research MR scan. The abnormality may be a benign "normal variant" or may be something more serious. Most researchers at the Martinos Center are not trained to make this distinction (nor is the research study the appropriate situation for clinical diagnosis). However, it is important that investigators be prepared to handle such an event should it occur.
- Research Data and Clinical Diagnosis
- If an Abnormality is Suspected
- Deciding to Terminate the Study
- Additional Information
Research Data and Clinical Diagnosis
Subjects participating in research experiments should be advised beforehand that the imaging data to be acquired is not equivalent to a diagnostic work-up. This should be stressed verbally and stated explicitly in the informed consent document. Similarly, when a research subject asks, "So does my brain look OK?", the investigator's response should be to reiterate the above.
For certain studies (especially those involving clinical populations, MGH patients, or others for whom the likelihood of discovering abnormalities is high), it is recommended (and sometimes required by the IRB) that arrangements be made by the PI for clinical readings of all MR scans acquired. For these studies, a procedure for acquiring appropriate images and handling clinical situations should be included in the research protocol, and explained in the informed consent document.
If an Abnormality is Suspected
If you suspect an abnormality during a scanning session, contact the radiologist on duty at Bay 1 (the clinical magnet), and request an immediate consultation while the subject is still in the magnet. The radiologist may suggest that additional images be collected before making a recommendation. Often the radiologist will be able to rule out a problem and save the subject the trouble of having to seek clinical follow-up. If clinical follow-up is recommended, the radiologist (and not the researcher) should convey this to the subject.
If no radiologist is available for immediate consultation, the researcher should print films of the brain area in question. If the potential abnormality was detected on the T1-weighted image, the researcher should take an additional T2-weighted scan. This short sequence can be found at the end of the Standard Brain Mapping protocol on both the 1.5T and 3.0T magnets.
At the earliest opportunity following the research study, arrange consultation with Greg Sorensen, MD, or another available radiologist. If the radiologist recommends clinical follow-up, the radiologist (and not the researcher) should contact the subject and convey this recommendation.
The researcher should never discuss the potential abnormality with the subject before a radiologist has been consulted and the situation has been explained to the subject by a medical professional.
Deciding to Terminate the Study
The researcher may or may not decide to terminate the study. In either case, care should be taken not to alarm the subject. The potential brain abnormality should not be discussed with the subject at this time.
If additional questions arise concerning a specific case, the investigator may seek the advice of the MGH Human Subjects Optimum Care Committee (617-726-2988).
If a subject does not have insurance or cannot pay for recommended medical services, they may contact the MGH Social Services Office (617-726-2640).
Greg Sorensen, MD