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

Sponsor
prof. dr. Koen Van Laere
Study ID
NCT07595666
Status
Enrolling By Invitation

Conditions

  • ALS - Amyotrophic Lateral Sclerosis
  • Alzheimer s Disease
  • Brain Tumors
  • Dementia
  • Epilepsy
  • Fronto-temporal Dementia
  • Head and Neck Tumors
  • Large Vessel Vasculitis
  • Lewy Body Dementia
  • Movement Disorders
  • Neuroblastoma
  • PARKINSON DISEASE (Disorder)
  • Parathyroid Adenomas
  • Pituitary Adenoma

Eligibility Criteria

Sex
ALL
Age
28 Days - N/A
Healthy Volunteers
Accepted

Interventions

  • Standard-of-care PET/CT — DEVICE
    This PET/CT is the routinely used clinical PET/CT scan
  • NeuroEXPLORER — DEVICE
    This is the new ultra-high resolution PET/CT scan

Study Details

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.

Key Dates

Start date
Sep 30, 2025
Status verified
May 2026
Primary completion
Aug 31, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
1,600 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: single arm: PET/CT comparison
    All participants undergo a scan on both PET/CT systems. First the Standard-of-care PET/CT and immediately after a scan on the NeuroEXPLORER.

Primary Outcome Measure

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. [ Time Frame: From enrollment until two weeks after the scan ]

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