NCT07274397 Assessment of Early Post-operative Nuclear Imaging in Neurosurgery: a Safety and Feasibility Study in Patients Operated for Glioblastoma
| NCT ID | NCT07274397 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beta Emitting Accurate Monitored Systems |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-04-17 |
| Primary Completion | 2027-04-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2026-04-17 with a primary completion date of 2027-04-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07274397 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07274397 currently recruiting?
Yes, NCT07274397 is actively recruiting participants. Contact the research team at contact@beams.bio for enrollment information.
Where is the NCT07274397 trial being conducted?
This trial is being conducted at Créteil, France.
Who is sponsoring the NCT07274397 clinical trial?
NCT07274397 is sponsored by Beta Emitting Accurate Monitored Systems. The trial plans to enroll 15 participants.
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