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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dynamic [18-FDG PET] scan post stereotactic radiation for brain metastases | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of dynamic PET | Diagnostic accuracy will be calculated and compared based on the index lesion. | 12-month follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcomes | Clinical outcomes such as local recurrence. | 24-month follow-up |
| Clinical outcomes | CNS progression-free survival and overall survival will be analyzed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maureen Dougan | Contact | 519 685 8500 | 35352 | maureen.dougan@sjhc.london.on.ca |
| Melody Qu | Contact | 519 685 8500 | 53025 | melody.qu@lhsc.on.ca |
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| 24-month follow-up |
| Clinical outcomes | Factors impact on these outcomes will be explored. | 24-month follow-up |
| Diagnostic imaging outcomes | GMR-to-perfusion ratio. | 24-month follow-up |
| Diagnostic imaging outcomes | Blood-brain barrier permeability to glucose. | 24-month follow-up |
| Diagnostic imaging outcomes | Glucose Metabolic Rate. | 24-month follow-up |
| Diagnostic imaging outcomes | Magnetic resonance spectroscopy data. | 24-month follow-up |
| Diagnostic imaging outcomes | Other ancillary clinical data will be explored. | 24-month follow-up |
| Cost-effectiveness analysis | 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. | 24-month follow-up |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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