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| Name | Class |
|---|---|
| KU Leuven | OTHER |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm: PET/CT comparison | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard-of-care PET/CT | Device | This PET/CT is the routinely used clinical PET/CT scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | From enrollment until two weeks after the scan |
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and feasibility of ultra-high resolution PET/CT (MDR generic masterprotocol EUDAMED CIV-25-06-053398) | 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. | From enrollment until 1 week after the scan |
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Inclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39638433 | Background | Omidvari N, Shanina E, Leung EK, Sun X, Li Y, Mulnix T, Gravel P, Henry S, Matuskey D, Volpi T, Jones T, Badawi RD, Li H, Carson RE, Qi J, Cherry SR. Quantitative Accuracy Assessment of the NeuroEXPLORER for Diverse Imaging Applications: Moving Beyond Standard Evaluations. J Nucl Med. 2025 Jan 3;66(1):150-157. doi: 10.2967/jnumed.124.268309. | |
| 38871391 |
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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.
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| NeuroEXPLORER | Device | This is the new ultra-high resolution PET/CT scan |
|
| From enrollment until two weeks after study visit |
| Quality of life (QOL) questionnaire | 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. | From enrollment until one year after the study visit |
| Impact on decision-making | 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. | From enrollment until 1 year after study visit |
| Li H, Badawi RD, Cherry SR, Fontaine K, He L, Henry S, Hillmer AT, Hu L, Khattar N, Leung EK, Li T, Li Y, Liu C, Liu P, Lu Z, Majewski S, Matuskey D, Morris ED, Mulnix T, Omidvari N, Samanta S, Selfridge A, Sun X, Toyonaga T, Volpi T, Zeng T, Jones T, Qi J, Carson RE. Performance Characteristics of the NeuroEXPLORER, a Next-Generation Human Brain PET/CT Imager. J Nucl Med. 2024 Aug 1;65(8):1320-1326. doi: 10.2967/jnumed.124.267767. |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D009069 | Movement Disorders |
| D000690 | Amyotrophic Lateral Sclerosis |
| D004827 | Epilepsy |
| D001932 | Brain Neoplasms |
| D010911 | Pituitary Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D010282 | Parathyroid Neoplasms |
| D009447 | Neuroblastoma |
| D010300 | Parkinson Disease |
| D020961 | Lewy Body Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013118 | Spinal Cord Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D007029 | Hypothalamic Neoplasms |
| D015173 | Supratentorial Neoplasms |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D010279 | Parathyroid Diseases |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D000080874 | Synucleinopathies |
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