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

NCT07274397 | Not Yet Recruiting DMC

• 2 other identifiers: Beams_EBP_252025-A01745-44
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glioblastoma; Brain Tumors; Brain Imaging

Keywords

Glioblastoma; brain tumors; PET-MRI; 18F-DOPA; Radiotracer; Diagnostic Imaging; Nuclear Medicine

Outcome Measures

Primary Outcomes (5)

• Assess the feasibility of performing early post-operative brain PET-MRI in neurosurgery patients

  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.

  Within 24 hours after surgery

• Assess the safety of performing early post-operative brain PET-MRI in neurosurgery patients

  by collecting side effects associated with radiotracer injection and imaging procedure after surgery during the inclusion period

  Within 24 hours after surgery

• Assess the safety of performing early post-operative brain PET-MRI in neurosurgery patients

  by measuring ambient gamma dose rate at several time points (Hour 0, Hour 1, Hour 2, Hour 4 et Hour 24) on different points according to appendix.

  Whithin 24 hours after surgery

• Assess the safety of performing early post-operative brain PET-MRI in neurosurgery patients

  by measuring ambient gamma dose rate at several time points on different points (on the patient, 50 centimeters, 1 meter, 2 meters from the patient) according to appendix.

  Whithin 24 hours afin surgery

• Assess the safety of performing early post-operative brain PET-MRI in neurosurgery patients

  With total dosimetry after 24 hours

  Whithin 24 hours afin surgery

Secondary Outcomes (8)

• Validate a nuclear imaging protocol to measure residual tumor volume on early post-operative brain PET-MRI in neurosurgery patients

  24 hours

• Evaluate the inter-raters reliability of nuclear imaging protocol (T/S and T/CC) to evaluate the presence or absence of residual tumor on early post-operative brain PET in neurosurgery patients.

  24 hours

• Evaluate the inter-raters reliability of nuclear imaging protocol (metabolic volume with different thresholds) to measure residual tumor volume on early post-operative brain PET in neurosurgery patients.

  24 hours

• Validate a nuclear imaging protocol to measure residual tumor volume on early post-operative brain PET-MRI in neurosurgery patients

  24 hours

• Validate a nuclear imaging protocol to measure residual tumor volume on early post-operative brain PET-MRI in neurosurgery patients

  24 hours

Study Arms (1)

Early post-operative PET-MRI group

OTHER

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.

Diagnostic Test: Early post-operative brain PET-MRI with 18F-DOPA and Gadolinium

Interventions

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

This intervention consists of a combined brain PET-MRI imaging session performed within 48 hours after surgical resection of a suspected glioblastoma. The PET scan uses 18F-DOPA as the radiotracer, administered intravenously at a dose of 2 MBq/kg, with static brain acquisition starting immediately post-injection. The MRI includes standard sequences and gadolinium-based contrast-enhanced imaging. The goal is to assess the feasibility and safety of this early post-operative imaging procedure, and to validate imaging parameters for the detection of residual tumor. Radiation dosimetry and potential adverse events related to imaging agents will be monitored.

Early post-operative PET-MRI group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beta Emitting Accurate Monitored Systems: lead
• Assistance Publique - Hôpitaux de Paris, FRANCE: collaborator

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Caroline Apra, MD, PhD

CONTACT

+330149812240; contact@beams.bio

Nawel Saci, Msc

CONTACT

+33667405900; nawelsaci@larechercheclinique.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study follows a single-group, open-label, prospective design. All participants will receive the same diagnostic intervention: an early post-operative PET-MRI using 18F-DOPA and gadolinium-based contrast agent. The aim is to assess feasibility, safety, and imaging performance without a control arm.

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: December 10, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-09