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

NCT07632092 | Recruiting

• 1 other identifier: PI2026_843_0020
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Short Time Examination; Brain Metastases; Radiation Necrosis

Keywords

18F]-FDG PET; Short Time Examination; Brain Metastases; Radiation Necrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• association between kinetic uptake parameters and diagnosis

  12 months

Interventions

CT scan OTHER

The patient is installed in the PET camera as soon as he is injected, so that early fixation of the \[18F\]-FDG radiotracer can be recorded for 15 minutes. As part of this acquisition, a CT scan dedicated for attenuation correction is also performed. Both this scan and the late scan will be carried out at ultra--low dose so that the total dose received by the patient does not exceed what he would have received without this research. The patient's total examination time remains unchanged

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHRU Amiens

Amiens, France

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Antoine GIRARD

CONTACT

33+3 22 45 03 81; Girard.Antoine@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): November 18, 2028
• Study Completion (Estimated): November 18, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)