Incidental findings

Note: to make use of the procedure described below, you must use the text as provided below in your subject information and informed consent.

Information

Every now and then a researcher may notice an abnormality on a structural MRI scan of a - supposedly healthy - participant or of a patient. Rarely (in less than 5% of the cases) does it concern an abnormality that requires further action.

To be clear, this only concerns abnormalities that may have consequences for a participant’s or patient’s health but that are treatable. The Medical Ethics Committee of the AMC does not deem it correct to burden a healthy participant with an untreatable incidental finding. It is another matter if it concerns a participant who does experience adverse effects (that can be traced back to the incidental finding), but these will generally not be healthy participants.

If you notice an abnormality on an MRI and wonder whether it is a relevant finding (something serious; not artefacts or white matter abnormalities, but something that may have consequences for a participant’s or patient’s health) you can apply for an assessment by a neuroradiologist from the Radiology department. Please first consult the Spinoza Centre staff or colleagues from your research group.

Procedure

Reporting an incidental finding goes according to the following procedure:

• If you encounter an abnormality during scanning and if time allows, run an additional structural scan:
  • At the 3T, run a FLAIR.
  • At the 7T, run a T2-weighted scan.
    These protocols can be found in the exam card Hospital -> Standard -> Incidental finding at both scanners.
• Fill in the incidental findings request form. Note: you can omit the insurance number and Acc#.
  • Clearly indicate, in the top right block next to Acc# and the exclamation points, the patient name as entered in the patient registration.
• Send your structural scans to “AMC-classic” (via Administration -> 'Send to network'). Specifically you should transfer (if acquired):
  • a T1-weighted scan.
  • a FLAIR or T2-weighted scan. If it is not possible to provide a T2-weighted scan, but you do have EPI images, provide a single dynamic hoe? together with the T1.
• Give the form (ideally scanned) to Trijntje, who will forward the information to the radiologist.
• The radiologist writes a report with the outcome of the examination.
• The researcher then notifies the general practitioner of the participant about the outcome in case of a positive finding.

Text to include in the subject information leaflet

Use this text for your projects. It has been drawn up in consultation with the Neuroradiology department and approved by the METH.

Dutch

Er is een kleine kans dat het onderzoek aanwijzingen oplevert dat u een hersenbeschadiging heeft, zoals een hersentumor. In dat geval sturen wij de MRI van uw hoofd door naar een radioloog die de vondst controleert. Als deze bevestigt dat het een bevinding betreft waarvoor medisch behandelen noodzakelijk wordt geacht, dan wordt deze informatie door de onderzoeker aan uw huisarts doorgegeven. In een enkel geval kan het voorkomen dat ook een niet klinisch relevante bevinding wordt doorgegeven. Om deze reden hebben wij de naam en woonplaats van uw huisarts nodig. Mocht u niet akkoord zijn met deze procedure dan kunt u niet deelnemen aan het onderzoek. We willen u erop wijzen dat de laborant / onderzoeker niet in staat is alle vormen van hersenbeschadiging te detecteren en dat het ook niet mogelijk is alle hersenbeschadigingen op de MRI scan die we van uw hoofd nemen te zien.

English

There is a small chance that the scan shows indications of some form of brain damage, such as a tumour. Should the scan result warrant it, we shall forward the MRI scan of your head to a radiologist to check this finding. If the radiologist confirms a finding that may have consequences for your health but is treatable, this information will be passed on to your general practitioner by the researcher. In rare cases, a finding that is not clinically relevant might also be communicated. To this end we require the contact information of your general practitioner. Should you not agree with the forwarding of this information to your general practitioner we regret that you cannot take part in the project. We therefore ask you to provide the name and city of residence of your general practitioner. Please note that the technician / researcher is unable to detect all forms of brain damage and that not every form of brain damage will show up on the MRI scan of your head.

Text for informed consent form

Dutch

Ik geef toestemming om op de hoogte te worden gebracht van onverwachte bevindingen waarvoor medisch behandelen noodzakelijk wordt geacht.

English

I hereby agree that in case of an incidental finding that requires medical treatment I and my general practitioner may be notified.