Actively Recruiting
Assessment of Early Post-operative Nuclear Imaging in Neurosurgery: a Safety and Feasibility Study in Patients Operated for Glioblastoma
Led by Beta Emitting Accurate Monitored Systems · Updated on 2026-06-08
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Beta Emitting Accurate Monitored Systems
Lead Sponsor
A
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of early post-operative brain PET-MRI imaging in adults who have undergone surgery for suspected glioblastoma. The study aims to validate specific nuclear imaging parameters to improve detection of residual tumor tissue compared to standard gadolinium-enhanced MRI. This prospective interventional diagnostic study will include 15 patients at a single site in France, focusing on imaging within 48 hours after surgery and monitoring for side effects related to the imaging procedures. Participants will undergo combined PET-MRI imaging using 18F-DOPA as the radiotracer and gadolinium-based contrast for MRI enhancement. The PET scan involves an intravenous injection of 18F-DOPA at 2 MBq/kg with static brain acquisition starting immediately after injection. MRI sequences include diffusion, spectroscopy, perfusion, and angiography scans. Patients will be monitored for radiation exposure and any adverse events during and after imaging, with a total monitoring period of 24 hours post-procedure. During the study, participants receive a pre-surgical baseline evaluation including medical history, PET-MRI, and MRI scans within 30 days to 2 days before surgery. After surgery, informed consent is obtained, followed by post-operative PET-MRI imaging and monitoring in the nuclear medicine department. Dosimetry measurements occur over 24 hours to assess radiation exposure. Safety assessments include observation for hypersensitivity or side effects related to gadolinium or 18F-DOPA. The study lasts approximately 24 hours per patient, with follow-up managed by the usual neurosurgical care team.
CONDITIONS
Brief Title
Assessment of Early Post-operative Nuclear Imaging in Neurosurgery: a Safety and Feasibility Study in Patients Operated for Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- First resection for a suspected glioblastoma in the past 72 hours
- Signed informed consent
- Adults aged 18 years or older
You will not qualify if you...
- 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
- Any postoperative behavioral disorders or medical condition impeding brain imaging
- Postoperative medical dependency preventing transfer to nuclear medicine
- Postoperative histological diagnosis different from glioblastoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits including pre-surgical baseline evaluation within 30 to 2 days prior to surgery
Duration - 1 day
Participants undergo neurosurgical procedure for tumor resection under general anesthesia.
Surgery day (in-person)
Duration - Up to 2 days
Participants receive early post-operative brain PET-MRI imaging with 18F-DOPA and gadolinium-based contrast within 48 hours after surgery. Radiation exposure and potential adverse events related to imaging agents are monitored.
1 visit including radiotracer injection, PET-MRI acquisition, and monitoring for at least 30 minutes post-imaging
Duration - 24 hours
Participants are monitored for 24 hours post imaging to assess radiation dosimetry and safety outcomes.
Continuous monitoring over 24 hours with dosimeter measurements
Trial Site Locations
Total: 1 location
1
Hôpital Henri Mondor - Université Paris-Est Créteil (UPEC)
Créteil, France, 94010
Actively Recruiting
Research Team
C
Caroline Apra, MD, PhD
N
Nawel Saci, Msc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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