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

14 maggio 2026 aggiornato da: prof. dr. Koen Van Laere

Prospective Comparison of Ultra-high Resolution 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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

1600

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Belgio
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgio, 3000
        • UZ Leuven

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: Standard-of-care PET/CT
This PET/CT is the routinely used clinical PET/CT scan
Altri nomi:
  • GE MI4 PET/CT
  • Siemens Vision X PET/CT
Dispositivo: NeuroEXPLORER
This is the new ultra-high resolution PET/CT scan

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Lasso di tempo: 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
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.
Lasso di tempo: 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.
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.
Lasso di tempo: 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.
From enrollment until two weeks after study visit

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Safety and feasibility of ultra-high resolution PET/CT (MDR generic masterprotocol EUDAMED CIV-25-06-053398)
Lasso di tempo: 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.
From enrollment until 1 week after the scan
Quality of life (QOL) questionnaire
Lasso di tempo: 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.
From enrollment until one year after the study visit
Impact on decision-making
Lasso di tempo: 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.
From enrollment until 1 year after study visit

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

prof. dr. Koen Van Laere

Collaboratori

KU Leuven

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 settembre 2025

Completamento primario (Stimato)

31 agosto 2030

Completamento dello studio (Stimato)

31 agosto 2030

Date di iscrizione allo studio

Primo inviato

27 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 maggio 2026

Primo Inserito (Effettivo)

19 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CIV-25-06-053414

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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