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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeta Emitting Accurate Monitored Systems

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators

Beta Emitting Accurate Monitored Systems

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Collaborator