By InvitationNot Applicable

Comparison of NeuroEXPLORER PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region.

Belgium1,600 participantsStarted 2025-09-30

Plain-language summary

The goal of this clinical study is to compare the current standard-of-care PET/CT scanner with the new NeuroEXPLORER PET/CT, with the aim of demonstrating the added diagnostic value of the new scanner. As this is the first device of its kind in Europe, the study will also evaluate the safety and general feasibility of the NeuroEXPLORER system for head and neck PET studies. Due to to its high resolution, the NeuroEXPLORER enables an accurate investigation of areas up to 20 times smaller than what can be visualized with standard clinical PET scanners, providing images with a very high level of detail. This scanner is specifically designed for imaging the brain, spinal cord, and neck region, to support the diagnosis and monitoring of neurological, psychiatric, and other disorders in the head and neck. The main questions this study aims to answer are: * Does the NeuroEXPLORER provide more detailed information with better diagnostic quality compared to standard clinical PET/CT scans for head and neck disorders? * Is the NeuroEXPLORER system safe and effective in performing head and neck studies? Participants will: * receive clear information about the study, including its organization, possible risks, and potential benefits. Based on this, they will be able to give their informed consent by signing an informed consent form before the study begins. * visit the clinic (UZ Leuven) once for two consecutive PET/CT scans: first the prescribed clinical scan, followed by a shorter scan with the NeuroEXPLORER. * before the start of the regular PET/CT scan, have a small catheter placed in a blood vessel in the forearm. Through this, a tracer will be administered. A tracer is a small amount of slightly radioactive material that helps to produce images of processes inside the body. Depending on the tracer used, the PET/CT scan may start immediately or after a short waiting period. * lie on their back on the scanner bed for 10 to 30 minutes during the clinical scan. * after the clinical scan, undergo a 15-20 minute scan on the NeuroEXPLORER. * leave the hospital after completing both scans. * afterwards, be asked whether they experienced any discomfort during the study. In addition, they will receive a one-time follow-up phone call within a week after the scan to check if they experienced any discomfort in the days following the study.

Who can participate

Age range

28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All subjects referred for standard-of-care PET in the indications for the substudies are eligible. Exclusion Criteria: * Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity beginning 4 days prior to tracer injection up to 1 day after tracer injection. * Subject does not understand the study procedures. * Subject is unwilling or unable to perform all of the study procedures or is considered unsuitable in any way by the principal investigator. * Subject has had exposure to ionizing radiation (\> 1 mSv) in other research studies within the last 12 months. * Subject does not agree that incidental findings are communicated to the general practitioner and to the participant him/herself. * Incapacitated patients that cannot give consent by themselves (in particular for substudies 1-3 in neurodegeneration).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is comparing a newer ultra-high resolution PET/CT scanner called NeuroEXPLORER against the standard PET/CT I might already be getting, does participating actually change my treatment plan, or is the experimental scan being done in addition to my usual care?
2Given that this trial is 'enrolling by invitation only,' how would I or my care team find out if I've been identified as a potential candidate, and what criteria are being used to select participants?
3Because this study covers a very wide range of conditions — from Alzheimer's and Parkinson's to head and neck cancers and vasculitis — how is the trial specifically relevant to my diagnosis, and will the results it generates apply meaningfully to my particular condition?
4The trial is measuring whether the new scanner is more accurate or gives doctors more confidence in their diagnosis — does that mean there's a chance the higher-resolution scan could reveal something about my condition that the standard scan might miss, and how would my care team act on that information?
5Since this appears to be a diagnostic imaging comparison rather than a treatment trial, are there any radiation exposure differences between the NeuroEXPLORER scan and my standard PET/CT that I should weigh before deciding whether to take part?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference in diagnostic accuracy and/or diagnostic confidence of ultra-high resolution PET/CT compared to standard PET/CT and validated against clinical follow-up, or pathological/surgical outcomes in neurodegenerative disorders.

Timeframe: From enrollment until two weeks after the scan

Timeframe: From enrollment until two weeks after study visit

Comparison of the sensitivity, specificity and accuracy of ultra-high resolution PET vs. standard-of-care PET for the diagnosis of vasculitis and giant cell arteritis, using clinical and pathological confirmation as the benchmark.

Timeframe: From enrollment until two weeks after study visit

Trial details

NCT IDNCT07595666

Sponsorprof. dr. Koen Van Laere

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-08-31

View on ClinicalTrials.gov More Dementia trials

Plain-language summary

Who can participate

Age range

28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Timeframe: From enrollment until two weeks after the scan

Timeframe: From enrollment until two weeks after study visit