Assessment of Early Post-operative Nuclear Imaging in Neurosurgery: a Safety and Feasibility Study in Patients Operated for Glioblastoma

Sponsor
Beta Emitting Accurate Monitored Systems
Study ID
NCT07274397
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Early post-operative brain PET-MRI with 18F-DOPA and Gadolinium — DIAGNOSTIC_TEST
    This intervention consists of a combined brain PET-MRI imaging session performed within 48 hours after surgical resection of a suspected glioblastoma. The PET scan uses 18F-DOPA as the radiotracer, administered intravenously at a dose of 2 MBq/kg, with static brain acquisition starting immediately post-injection. The MRI includes standard sequences and gadolinium-based contrast-enhanced imaging. The goal is to assess the feasibility and safety of this early post-operative imaging procedure, and to validate imaging parameters for the detection of residual tumor. Radiation dosimetry and potential adverse events related to imaging agents will be monitored.

Study Details

This clinical trial aims to evaluate the feasibility and safety of early post-operative brain PET-MRI imaging in adult patients who have undergone surgery for suspected glioblastoma. The study also seeks to validate specific nuclear imaging parameters for better detection of residual tumor tissue compared to standard gadolinium-enhanced MRI. The main objectives are to determine whether early PET-MRI within 48 hours post-surgery is feasible, to assess potential side effects related to imaging procedures, and to explore if PET parameters such as SUVmax, metabolic volume, and tumor-to-striatum ratio can improve the detection of tumor residue. A total of 15 patients will be included at a single site in France. Participants will undergo PET-MRI using 18F-DOPA and gadolinium, and will be monitored for radiation exposure and possible adverse events up to 24 hours after imaging.

Key Dates

First listed
Dec 10, 2025
Start date
Apr 17, 2026
Status verified
Jun 2026
Primary completion
Apr 17, 2027
Completion
Apr 17, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Early post-operative PET-MRI group
    Participants in this arm will undergo early post-operative PET-MRI imaging within 48 hours after surgical resection of a suspected glioblastoma. The imaging procedure includes a brain MRI with gadolinium-based contrast and a PET scan using 18F-DOPA as the radiotracer. Patients will be monitored for potential adverse events related to the imaging agents and for radiation exposure. No therapeutic intervention will be administered. The purpose of this diagnostic intervention is to assess feasibility, safety, and imaging performance in detecting residual tumor tissue.

Primary Outcome Measure

Assess the feasibility of performing early post-operative brain PET-MRI in neurosurgery patients [ Time Frame: Within 24 hours after surgery ]

Central Contacts

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