RecruitingNot ApplicableNCT07274397

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

Enrollment

15 participants

Start Date

Apr 17, 2026

Study Type

INTERVENTIONAL

Conditions

Glioblastoma Brain Tumors Brain Imaging

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

First resection for a suspected glioblastoma in the past 72h
Signed informed consent
Deprived of liberty or under legal protection (e.g, guardianship, trusteeship)
Patients under 18 years old
Absence of social security cover
Pregnancy
Emergency procedure
Contraindication to brain MRI, including claustrophobia
Contraindication to radiotracers or gadolinium injection
Preoperative cognitive impairment impeding patient information

Exclusion Criteria3

Any postoperative behavioral disorders or medical condition or symptom impeding the completion of brain imaging
Postoperative medical dependency impeding the patient transfer to the nuclear medicine department (including, but not limited to, invasive ventilation, need for external ventricular drainage…)
Postoperative histological diagnosis different from glioblastoma

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Interventions

DIAGNOSTIC_TESTEarly post-operative brain PET-MRI with 18F-DOPA and Gadolinium

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.