Early [18F]-FDG PET Dynamic Analysis in Brain Metastases After Radiotherapy. (DYNFDGTEP)

Interest of Early Dynamic Analysis of [18F]-FDG PET Images in the Differential Diagnosis Between Recurrence and Radionecrosis in Brain Metastases.

Various treatment options are available for brain metastases, depending on factors such as lesion site or number lesions. Radiotherapy is a commonly used treatment. Following stereotactic radiotherapy for brain metastases, a potential complication, namely brain radionecrosis, can occur subsequently. It is essential to differentiate between this radionecrosis and lesion recurrence in order to determine the appropriate treatment approach. Contrast-enhanced magnetic resonance imaging (MRI) is the most widely used technique for monitoring brain metastases. Therefore, patients undergo routine MRI at 3 months and during subsequent follow-ups, but if the lesion evolve and if distinguishing between recurrence and radionecrosis is challenging, an [18F]-FDG PET scan is then prescribed by oncologists or radiotherapists during follow-up consultations. As part of the standard patient management protocol, a 10-minute image acquisition begins after a 45-60 minutes wait following the radiotracer injection. A second image acquisition is then conducted 3-4 hours later. For both acquisitions, a low-dose X-ray scanner is synchronously coupled to allow attenuation correction of the PET images.

Patient for whom a [18F]-FDG PET cerebral examination has been prescribed as part of the usual management of brain metastases will be eligible to the protocol. If the patient agrees to participate, an early imaging session is initiated immediately upon radiotracer injection, lasting 15 minutes in addition to the standard acquisition protocol.

Study Overview

• Status: Recruiting
• Conditions: Brain Metastases; Radiation Necrosis; Short Time Examination
• Intervention / Treatment: Other: CT scan

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Antoine GIRARD; Phone Number: 33+3 22 45 03 81; Email: Girard.Antoine@chu-amiens.fr

Study Locations

• France
  • Amiens, France
    • Recruiting
    • CHRU Amiens
    • Sub-Investigator: Alexandre COUTTE, MD
    • Sub-Investigator: Mathieu BOONE, MD
    • Contact: Antoine GIRARD, MD; Phone Number: 33+3 22 45 03 81; Email: Girard.Antoine@chu-amiens.fr
    • Sub-Investigator: Ismaël NEJJAR, MD
    • Sub-Investigator: Marc-Etienne MEYER, Pr
    • Sub-Investigator: Chalabia FERGANI, MD
    • Sub-Investigator: Florent Hives, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient for whom a [18F]-FDG PET cerebral examination has been prescribed as part of the usual management of brain metastases will be eligible to the protocol

Description

Inclusion Criteria:

• Patient referred for cerebral [18F]-FDG PET examination prescribed as part of his usual medical care for brain metastasis.
• Age ≥ 18 years old
• Affiliation to a social security program
• Ability of the subject to understand and express his consent

Exclusion Criteria:

• Age under 18 years old
• Person under guardianship or curatorship
• Pregnant or breastfeeding woman
• Primary brain tumors
• Brain metastases from renal, thyroid or other cancers known to have low avidity for [18F]-FDG

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ratio between lesion maximum activity and controlateral healthy tissue activity	Value of the measurement of the ratio of the maximum activity within the lesion to the average activity within the region of interest of the contralateral healthy tissue.	day1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
association between kinetic uptake parameters and diagnosis	association between kinetic uptake parameters from compartmental models and the differential diagnosis of radionecrosis and recurrence of brain metastases treated by radiotherapy	12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2026
• Primary Completion (Estimated): November 18, 2028
• Study Completion (Estimated): November 18, 2028

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Brain Metastases; Radiation Necrosis; 18F]-FDG PET; Short Time Examination
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: PI2026_843_0020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No