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.
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
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
Single group
Early post-operative brain PET-MRI with 18F-DOPA and Gadolinium
Diagnostic testThis 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.
Assess the feasibility of performing early post-operative brain PET-MRI in neurosurgery patients
by recording the rate of patients excluded after inclusion for non-realized imaging or incomplete imaging, at the physician's or the patient's demand.
Assess the safety of performing early post-operative brain PET-MRI in neurosurgery patients
by collecting side effects associated with radiotracer injection and imaging procedure after surgery during the inclusion period
Assess the safety of performing early post-operative brain PET-MRI in neurosurgery patients
by measuring ambient gamma dose rate at several time points (Hour 0, Hour 1, Hour 2, Hour 4 et Hour 24) on different points according to appendix.
Assess the safety of performing early post-operative brain PET-MRI in neurosurgery patients
by measuring ambient gamma dose rate at several time points on different points (on the patient, 50 centimeters, 1 meter, 2 meters from the patient) according to appendix.
Validate a nuclear imaging protocol to measure residual tumor volume on early post-operative brain PET-MRI in neurosurgery patients
by varying different parameters in PET analysis and comparing the results with gadolinium enhanced MRI: Dynamic analysis including peak time
Evaluate the inter-raters reliability of nuclear imaging protocol (T/S and T/CC) to evaluate the presence or absence of residual tumor on early post-operative brain PET in neurosurgery patients.
Images will be reviewed by at least two raters : Kappa coefficient, Percentage agreement
Evaluate the inter-raters reliability of nuclear imaging protocol (metabolic volume with different thresholds) to measure residual tumor volume on early post-operative brain PET in neurosurgery patients.
Intra-class correlation coefficient
Validate a nuclear imaging protocol to measure residual tumor volume on early post-operative brain PET-MRI in neurosurgery patients
by varying different parameters in PET analysis and comparing the results with gadolinium enhanced MRI: Dynamic analysis including sleigh
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Beta Emitting Accurate Monitored Systems
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborator
