Clinical trial · Interventional
Assessment of Early Post-operative Nuclear Imaging in Neurosurgery: a Safety and Feasibility Study in Patients Operated for Glioblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Imaging | — | UNRESOLVED | — |
| Brain Tumors | Brain Neoplasm | ALIAS | 0.90 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early post-operative brain PET-MRI with 18F-DOPA and Gadolinium | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Early post-operative PET-MRI group
- description
- Participants in this arm will undergo early post-operative PET-MRI imaging within 48 hours after surgical resection of a suspected glioblastoma. The imaging procedure includes a brain MRI with gadolinium-based contrast and a PET scan using 18F-DOPA as the radiotracer. Patients will be monitored for potential adverse events related to the imaging agents and for radiation exposure. No therapeutic intervention will be administered. The purpose of this diagnostic intervention is to assess feasibility, safety, and imaging performance in detecting residual tumor tissue.
- interventionNames
- Diagnostic Test: Early post-operative brain PET-MRI with 18F-DOPA and Gadolinium
Primary outcomes (5)
- measure
- Assess the feasibility of performing early post-operative brain PET-MRI in neurosurgery patients
- timeFrame
- Within 24 hours after surgery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available