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

RecruitingNAAges 18 Years - anyAllBeta Emitting Accurate Monitored Systems
NCT07274397 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * First resection for a suspected glioblastoma in the past 72h * Signed informed consent non-inclusion Criteria: * 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 criteria : * 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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What it tests

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

1 site
Hôpital Henri Mondor - Université Paris-Est Créteil (UPEC)
Créteil, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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