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Enrolling by invitationNCT07595666Updated May 19, 2026

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

An interventional study of Standard-of-care PET/CT and NeuroEXPLORER in Dementia, Movement Disorders and ALS - Amyotrophic Lateral Sclerosis, sponsored by prof. dr. Koen Van Laere. Enrolling by invitation at 1 site in Belgium. Open to participants aged 28 Days and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-19.

Primary conditionLewy Body DiseaseRegistry: DementiaReclassifiedWhy we changed it
Registry
Dementia — the first condition term the registry derived for this study.
ClinicalTrials.gg
Lewy Body Disease
Why
  1. The study's listed conditions name Lewy Body Disease, a narrower term within Dementia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by prof. dr. Koen Van Laere · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Sep 2025, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
1,600
Allocation
Not applicable
Ages
28 Days and older
Sex
All
01

Study 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.
02

Conditions studied

  • 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

Keywords

  • NeuroEXPLORER PET/CT
  • prospective comparator study
  • disorders in the head and neck region
03

In context

Lewy Body Disease Reclassified

239 studies on the registry are indexed under Lewy Body Disease; 89 are open to participants now.

This study's planned enrollment of 1,600 is above the median of 89 across 152 interventional studies indexed under Lewy Body Disease.

Browse Lewy Body Disease studies →

Lead sponsor

prof. dr. Koen Van Laere is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Compared within Lewy Body Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dementia. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
28 Days and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All subjects referred for standard-of-care PET in the indications for the substudies are eligible.

Exclusion 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.

    • 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).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,600 participants (estimated)

Study 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.

    Device: Standard-of-care PET/CT · Device: NeuroEXPLORER

Interventions

  • DeviceStandard-of-care PET/CT

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

    Also known as: GE MI4 PET/CT, Siemens Vision X PET/CT

  • DeviceNeuroEXPLORER

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

06

What researchers measure

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.

    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

    Time frame: From enrollment until two weeks after the scan

  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.

    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.

    Time frame: From enrollment until two weeks after study visit

  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.

    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.

    Time frame: From enrollment until two weeks after study visit

Secondary outcomes

  1. 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.

    Time frame: From enrollment until 1 week after the scan

  2. 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.

    Time frame: From enrollment until one year after the study visit

  3. 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.

    Time frame: From enrollment until 1 year after study visit

07

Study locations

1 site
08

References and documents

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. PubMed 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):1320-1326. doi: 10.2967/jnumed.124.267767. PubMed 38871391 ↗

Individual participant data

Plan to share: Yes

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Aug 2030, 59 months after the start.

Of 58 non-industry interventional studies with no phase under Lewy Body Disease, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 61. This study's planned 59 months is above that.

Counting every sponsor, half of 62 studies reached it within 35 months; a quarter within 26 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 27, 2026
First posted
May 19, 2026
StartActual
Sep 30, 2025
Primary completionEst.
Aug 31, 2030
CompletionEst.
Aug 31, 2030
Last update
May 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07595666
Lead sponsor
prof. dr. Koen Van Laere
Collaborators
KU Leuven
Responsible party
prof. dr. Koen Van Laere (Prof. dr. Koen Van Laere, Universitaire Ziekenhuizen KU Leuven) — Sponsor-investigator
First posted
May 19, 2026
Start date
Sep 30, 2025
Primary completion
Aug 31, 2030 (estimated)
Completion
Aug 31, 2030 (estimated)
Last update
May 19, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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