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

NCT ID: NCT07274397

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-01-01

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.

Detailed Description

This study aims to assess safety and feasibility of early post-operative PET-MRI and validate imaging parameters for detecting glioblastoma residue, enabling future personalized post-surgical care.

The primary objectives are to :

• Asses the safety of performing early post-operative brain PET-MRI in neurosurgery patients after glioblastoma surgery.
• Measure the nuclear exposition of patients when performing early post-operative brain PET-MRI in neurosurgery patients.
• Assess the feasibility of performing early post-operative brain PET-MRI in neurosurgery patients.

It is a prospective interventional diagnostic study involving patient comparison Category RIPH. 15 patients will be included. This is a monocentric study. One surgical and including site (CHU Henri Mondor), in one country (France).

Patients will participate during 24 hours. The duration of the study is 12 months.

Following gadolinium injection, patients will be monitored for at least 30 minutes to allow for the early detection of potential side effects. Immediate hypersensitivity reactions, including anaphylactoid responses or other idiosyncratic effects, may present with cardiovascular, respiratory, or cutaneous symptoms, and can be severe.

Although delayed reactions are rare, most immediate events occur within the first 30 minutes post-administration. Monitoring is routinely implemented in clinical practice and will be applied accordingly in the study.

18F-DOPA injection can induce pain at the injection site, probably due to the acidity of the product. Given the minimal quantity of substance administered, the primary risk is associated with the exposure to ionizing radiation. In theory, such exposure may induce carcinogenesis or result in the development of hereditary defects. Nevertheless, since the effective dose is approximately 7 mSv and we are well below the maximum recommended activity of 280 MBq, the probability of these adverse effects occurring is considered very low.

2. MRI

1. Diffusion B1500

2. SWI

3. 3D FLAIR

4. 3D T1 SPACE

5. ASL

6. Spectroscopy (TE short et TE long) in the tumoral surroundings

7. After gadolinium injection : Perfusion T2*, Angio-MRI, 3DT1 SPACE

For PET-MRI imaging, tracer administration and acquisition timing will follow standard clinical protocols. For 18F-DOPA, a static brain acquisition will be performed between 10- and 30-minutes post-injection, as recommended for glioma imaging.

Study design is as follow :

• Pre-surgical baseline evaluation: 30 days - 2 days prior to surgery

• Patient information
• Medical History and Treatment, clinical assessment
• Preoperative Brain MRI and PET-MRI as detailed hereabove.

Patients usually undergo preoperative brain PET-MRI with gadolinium enhancement and 18F-DOPA injection as a standard of care. No specific period of time will be necessary to schedule the surgery after this imaging.

• D0: Neurosurgical procedure for tumor resection, as decided by the neurosurgeon, under general anesthesia
• Between D0 post-surgery and D2: patient informed consent and inclusion

• H0: Patient informed consent and inclusion
• Baseline medical examination
• Patient transferred to the nuclear medicine department
• Positioning of a dosimeter
• Radiotracer intravenous injection
• For suspected glioblastoma:

18F-Dopa 2MBq/kg, starting the imaging immediately after injection

• Postoperative brain PET-MRI acquisition
• Surveillance time in nuclear medicine according to standard procedures
• Patient transferred back to the neurosurgery department
• Surveillance time: 24 hours dosimetry measurements
• End of inclusion medical examination
• Removing the dosimeter
• H24: End of patient inclusion Neurosurgical follow-up and home discharge as established by the referent per clinical practice.

No medicinal product with therapeutic intent are administered in this study, only imaging agents usually used in clinical practice for diagnostic purposes are employed. The remainder of the patient's care will be managed according to the standard of care.

Only diagnostic imaging agents routinely used in standard clinical neuroimaging protocols will be administered during the study.

Gadolinium-based contrast agents will be used for MRI sequences requiring enhancement.

For PET imaging, 18F-DOPA will be employed. All imaging agents will be used under standard clinical conditions, in accordance with current safety and administration guidelines.

Conditions

Glioblastoma; Brain Tumors; Brain Imaging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris, FRANCE

UNKNOWN

Sponsor Role: collaborator

Beta Emitting Accurate Monitored Systems

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Caroline Apra, MD, PhD

Role: CONTACT

contact@beams.bio

+330149812240

Nawel Saci, Msc

Role: CONTACT

nawelsaci@larechercheclinique.com

+33667405900

Other Identifiers

Beams_EBP_25

Identifier Type: -

Identifier Source: org_study_id

2025-A01745-44

Identifier Type: OTHER

Identifier Source: secondary_id