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

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Early post-operative brain PET-MRI with 18F-DOPA and Gadolinium for people with brain imaging, brain tumors, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Hôpital Henri Mondor - Université Paris-Est Créteil (UPEC)

Créteil, France

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NCT07274397


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