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

Official title

Prospective Comparison of Ultra-high Resolution NeuroExplorer PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region

Overview

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

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

Primary outcome measures

• 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]
• 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. [Time frame: 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. [Time frame: From enrollment until two weeks after study visit]

Secondary outcome measures (3)

• Safety and feasibility of ultra-high resolution PET/CT (MDR generic masterprotocol EUDAMED CIV-25-06-053398) [Time frame: From enrollment until 1 week after the scan]
• Quality of life (QOL) questionnaire [Time frame: From enrollment until one year after the study visit]
• Impact on decision-making [Time frame: From enrollment until 1 year after study visit]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

Belgium · 1 center

• UZ Leuven — Leuven

Publications

• 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. PMID 39638433
• 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):1320-13 PMID 38871391

Identifiers

NCT: NCT07595666 · CIV-25-06-053414

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗