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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• First resection for a suspected glioblastoma in the past 72h

• Signed informed consent

Locations
Other Locations
France
Hôpital Henri Mondor - Université Paris-Est Créteil (UPEC)
RECRUITING
Créteil
Contact Information
Primary
Caroline Apra, MD, PhD
contact@beams.bio
+330149812240
Backup
Nawel Saci, Msc
nawelsaci@olexclinical.com
+33667405900
Time Frame
Start Date: 2026-04-17
Estimated Completion Date: 2027-04-17
Participants
Target number of participants: 15
Treatments
Other: Early post-operative PET-MRI group
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.
Sponsors
Collaborators: Assistance Publique - Hôpitaux de Paris
Leads: Beta Emitting Accurate Monitored Systems

This content was sourced from clinicaltrials.gov