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

Condition(s) studied

Investigational drug(s) / intervention(s)

Early 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.

Study 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

Primary outcome measure(s)

• Assess the feasibility of performing early post-operative brain PET-MRI in neurosurgery patients — Within 24 hours after surgery
  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 — Within 24 hours after surgery
  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 — Whithin 24 hours after surgery
  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 — Whithin 24 hours afin surgery
  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.
• Assess the safety of performing early post-operative brain PET-MRI in neurosurgery patients — Whithin 24 hours afin surgery
  With total dosimetry after 24 hours

Trial sites (1)

Other trials for the same condition