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

NCT ID: NCT06511323

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2027-08-31

Brief Summary

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.

Detailed 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.

Conditions

Brain Metastases

Study Design

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

Study Groups

Observational

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DIAGNOSTIC_TEST

at baseline prior to stereotactic radiation, at 10 weeks after treatment, and at first concern for progression at treated lesion or 12 months post-treatment, whichever comes earlier.

Interventions

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

at baseline prior to stereotactic radiation, at 10 weeks after treatment, and at first concern for progression at treated lesion or 12 months post-treatment, whichever comes earlier.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

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

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Melody Qu

Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Maureen Dougan

Role: CONTACT

maureen.dougan@sjhc.london.on.ca

519 685 8500 ext. 35352

Melody Qu

Role: CONTACT

melody.qu@lhsc.on.ca

519 685 8500 ext. 53025

Other Identifiers

124854

Identifier Type: -

Identifier Source: org_study_id