Brain Metastases
Conditions
Keywords
Dynamic F-18 FDG PET,, Brain metastases, Stereotactic radiation, Radio-necrosis, Pseudo-progression
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.
Interventions
DIAGNOSTIC_TESTdynamic [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.
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of dynamic PET | 12-month follow-up. | Diagnostic accuracy will be calculated and compared based on the index lesion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes | 24-month follow-up | Clinical outcomes such as local recurrence. |
| Diagnostic imaging outcomes | 24-month follow-up | GMR-to-perfusion ratio. |
| Cost-effectiveness analysis | 24-month follow-up | A decision analysis model coupled with Markov model will be constructed to estimate the incremental cost-effectiveness ratio (ICER) of performing dynamic PET in this setting from the Canadian health-care system perspective. |
Contacts
Primary ContactMaureen Dougan
Backup ContactMelody Qu
Outcome results
None listed