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. These procedures are provided as a service to Spinoza users. You can use the procedures at Spinoza, but you may also chose to follow other procedures, as long as they are approved by a Dutch Medical Ethics Committee (METC).

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.

Always inspect your structural scan during the scanning session. If you notice a potential abnormality and wonder whether it is a relevant finding (i.e., something that may have consequences for a participant’s or patient’s health) you can apply for an assessment by a neuroradiologist from the AUMC radiology department. Please first consult the Spinoza Centre staff or colleagues from your research group. When in doubt, there is no doubt; send it in for review.

The AUMC radiology department will only accept dicom images that are sent from the scanner console for review.

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 FLAIR.
    These protocols can be found in the exam card Hospital -> Standard -> Incidental finding at both scanners.
• Fill in this incidental findings document ; if possible in Dutch, and send the Word file together with a screenshot of your finding to support ([email protected]).
• Send your structural scans to “AMC-classic” (via Administration -> 'Send to network'). Specifically you should transfer (if acquired):
  • a T1-weighted scan.
  • a FLAIR. (if it is not possible to provide a FLAIR scan, but you do have EPI images, provide a single dynamic together with the T1).
  • if you acquired a T2-weighted scan, you could also send this as an addition.
• The radiologist writes a report with the outcome of the examination.
• If necessary the researcher then notifies the general practitioner of the participant in case of a positive finding. Make sure to inform the GP you have an incidental finding that might warrant further investigation by a neurologist, you did not perform a comprehensive structural MRI investigation and you are not clinically trained to interpret the findings (unless you are, of course...). Ask for an email to forward the radiological report.
• In some cases, the hospital requires the images on a physical disc (CD/DVD). These can be created by exporting the scans as (enhanced) DICOMs to a network location and then burning the (just the) file and folder using the declaration form PC next to the little kitchen. Copy the file and folder onto an empty disc and select the second burning option (and not the 'use as USB drive').

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 METC.

Dutch

Er is een kleine kans dat het onderzoek aanwijzingen oplevert dat u een hersenbeschadiging heeft. 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 bevinding wordt doorgegeven waar geen medisch behandelen noodzakelijk voor wordt geacht. 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 scan assistent/ 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. 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 for which medical treatment is deemed necessary, this information will be passed on to your general practitioner by the researcher. 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.