Clinical trial NCT06511323: Evaluation of Brain Metastases Treated With Stereotactic Radiotherapy Using Dynamic [18F]FDG PET
Official title: Evaluation of Brain Metastases Treated With Stereotactic Radiotherapy Using Dynamic [18F]FDG PET
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Brain Metastases
Keywords: Dynamic F-18 FDG PET,
Brain metastases
Stereotactic radiation
Radio-necrosis
Pseudo-progression
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Diagnostic accuracy of dynamic PET
timeFrame: 12-month follow-up.
Secondary outcomes:
measure: Clinical outcomes
timeFrame: 24-month follow-up
measure: Clinical outcomes
timeFrame: 24-month follow-up
measure: Clinical outcomes
timeFrame: 24-month follow-up
measure: Diagnostic imaging outcomes
timeFrame: 24-month follow-up
measure: Diagnostic imaging outcomes
timeFrame: 24-month follow-up
measure: Diagnostic imaging outcomes
timeFrame: 24-month follow-up
measure: Diagnostic imaging outcomes
timeFrame: 24-month follow-up
measure: Diagnostic imaging outcomes
timeFrame: 24-month follow-up
measure: Cost-effectiveness analysis
timeFrame: 24-month follow-up
Other outcomes:
Locations:
Study officials:
References: