Evaluation of Brain Metastases Treated With Stereotactic Radiotherapy Using Dynamic [18F]FDG PET

Lawson Health Research Institute

Status: Not yet enrolling

Conditions: Brain Metastases

Treatments: Diagnostic Test: dynamic [18-FDG PET] scan post stereotactic radiation for brain metastases

Study type: Interventional

Funder types: Other

Identifiers

NCT06511323

124854

Details and patient eligibility

About

The purpose of this study is to evaluate the clinical usefulness of dynamic [18F]FDG PET imaging in assessing brain metastasis post stereotactic radiotherapy to separate true progression from the treatment-related changes.

Full description

After being informed about the study and potential risk, all participants giving written informed consent will be screened to determine if participant being referred fits eligibility criteria for the study, under of the supervision of the radiation oncologist. If a participant agrees to participate in this study, they will receive three additional imaging sessions (the dynamic PET scan). The first session will occur prior to starting treatment; the second session will occur at about 10 weeks post treatment; the third session will occur at first concern of progression at treated lesions or 12 months post-treatment, whichever comes earlier. These scans will be scheduled in addition to the participant's regular follow-up scans and appointments.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or older.
• Willing and able to provide consent.
• ECOG 0-2.
• Life expectancy ≥12 months.
• Creatinine clearance ≥30 ml/min within 28 days prior to registration.
• At the discretion of the treating oncologist, it is believed that at least 1 lesion (or resection cavity) is best managed with SRS/SFR

Exclusion criteria

• Pregnant or nursing women.
• Men or women of childbearing potential who are unwilling to employ adequate contraception.
• Inability to complete a brain MRI.
• Known allergy to gadolinium.
• Inability to complete a PET scan.
• Uncontrolled diabetes mellitus.
• Primary germ cell tumour, primary CNS tumour, or lymphoma
• SRS/FSRT is no longer indicated for any BMs
• Must be able to read and write English

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Observational

Experimental group

Description:

This is a prospective, single-arm, pilot diagnostic study to evaluate the diagnostic accuracy of using dynamic \[18F\]FDG PET in 70 patients with brain metastases managed with stereotactic radiosurgery(SRS)/fractionated stereotactic radiotherapy (FSRT). The study will include imaging assessments at baseline, at 10 weeks after treatment, and at first concern for progression or 12 months post-treatment, whichever comes earlier.

Treatment:

Diagnostic Test: dynamic [18-FDG PET] scan post stereotactic radiation for brain metastases