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Enrolling by Invitation

NCT Number: NCT07595666

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

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.

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Key information

Conditions

Dementia ALS - Amyotrophic Lateral Sclerosis Alzheimer s Disease Amyotrophic Lateral Sclerosis Basal Ganglia Diseases Brain Diseases Brain Neoplasms Brain Tumors Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Epilepsy Fronto-Temporal Dementia Head and Neck Neoplasms Head and Neck Tumors Hypothalamic Diseases Hypothalamic Neoplasms Large Vessel Vasculitis Lewy Body Dementia Lewy Body Disease Mental Disorders Metabolic Diseases Motor Neuron Disease Movement Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroblastoma Neurocognitive Disorders Neurodegenerative Diseases Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Neuromuscular Diseases Nutritional and Metabolic Diseases PARKINSON DISEASE (Disorder) Parathyroid Adenomas Parathyroid Diseases Parathyroid Neoplasms Parkinson Disease Parkinsonian Disorders Pituitary Adenoma Pituitary Diseases Pituitary Neoplasms Proteostasis Deficiencies Spinal Cord Diseases Supratentorial Neoplasms Synucleinopathies TDP-43 Proteinopathies

Age range

28 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Standard-of-care PET/CT

Device

This PET/CT is the routinely used clinical PET/CT scan

Other names: GE MI4 PET/CT, Siemens Vision X PET/CT

NeuroEXPLORER

Device

This is the new ultra-high resolution PET/CT scan

Primary outcomes

  1. 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

    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

  2. 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

    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.

  3. 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

    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 outcomes

  1. 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

    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.

  2. Quality of life (QOL) questionnaire

    Time frame: 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.

  3. Impact on decision-making

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

prof. dr. Koen Van Laere

Other

Collaborators

  • KU Leuven

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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