Dementia, Movement Disorders, ALS - Amyotrophic Lateral Sclerosis, Epilepsy, Brain Tumors, Pituitary Adenoma, Large Vessel Vasculitis, Head and Neck Tumors, Parathyroid Adenomas, Neuroblastoma, PARKINSON DISEASE (Disorder), Lewy Body Dementia, Alzheimer s Disease, Fronto-temporal Dementia
Conditions
Keywords
NeuroEXPLORER PET/CT, prospective comparator study, disorders in the head and neck region
Brief 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.
Interventions
DEVICEStandard-of-care PET/CT
This PET/CT is the routinely used clinical PET/CT scan
DEVICENeuroEXPLORER
This is the new ultra-high resolution PET/CT scan
Sponsors
prof. dr. Koen Van Laere
KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
The primary endpoint of the study is a paired comparison between the clinical PET/CT and the NeuroEXPLORER where each subject is tested on both devices immediately after each other. The sequential scanning is not a cross-over design or randomisation design, in order to not interfere with the clinical PET/CT scan.
Eligibility
Sex/Gender
ALL
Age
28 Days to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From enrollment until two weeks after the scan | For the neurodegenerative indications (n=1000 subjects), standard-of-care (SOC) and ultra-high-resolution (UHR) PET images will be interpreted by three blinded nuclear medicine physicians using standardized MIM software workflows. Standard clinical criteria by the most recent EANM/SNMMI guidelines will be used for interpretation, supplemented by predefined new features unique to UHR images. Quantitative metrics, including standardized uptake values ratio (SUVR) and z-scores will be recorded in cortical regions and small nuclei of interest by semiquantitative region-based analysis based on a UHR brain atlas and normative database. Standard of truth will be the final clinical diagnosis established by expert memory clinical specialists at least 6 months after PET, based on MRI, SOC PET and fluid biomarkers |
| 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 head and neck cancer. | From enrollment until two weeks after study visit | Lesion detection/delineation and localization performance of the UHR vs. SOC PET will be compared by three blinded expert readers. Images will be co-registered with MRI where available for anatomical precision. Image quantification (semi-quantitative analysis) will include measurement of target-to-background ratio and lesion SUVmax. Standard of truth will be the combination of surgical/histopathological findings and biochemical follow-up. |
| 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. | From enrollment until two weeks after study visit | UHR and SOC PET scans will be analyzed by three nuclear medicine physicians. Vascular FDG uptake will be assessed by scoring the presence and intensity of uptake in various arterial segments. Semiquantitative metrics like SUVmax or target-to-background ratio will be obtained. Standard of truth will be the combination of clinical criteria and pathological biopsy confirmation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and feasibility of ultra-high resolution PET/CT (MDR generic masterprotocol EUDAMED CIV-25-06-053398) | From enrollment until 1 week after the scan | Any device specific adverse events (ADE or SADE), including performance parameters will be tracked. PROM (patient reported outcome measures) and patient tolerability will be monitored by a questionnaire taken immediately and one week (phone call) after the study investigation. |
| Quality of life (QOL) questionnaire | From enrollment until one year after the study visit | Change in health-related quality of life will be evaluated using the EQ-5D-5L (EuroQol) questionnaire. The questionnaire will be administered at baseline and at one year after the study visit. |
| Impact on decision-making | From enrollment until 1 year after study visit | Clinical impact will be quantified by the absolute number and proportion of cases in which UHR PET leads to a change in diagnosis, diagnostic confidence, management recommendation, lesion detection, lesion localization, or reader-rated clinical impact compared with standard-of-care PET. |
Countries
Belgium
Outcome results
None listed