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Trial Title:
Evaluation of Brain Metastases Treated With Stereotactic Radiotherapy Using Dynamic [18F]FDG PET
NCT ID:
NCT06511323
Condition:
Brain Metastases
Conditions: Official terms:
Neoplasm Metastasis
Brain Neoplasms
Fluorodeoxyglucose F18
Conditions: Keywords:
Dynamic F-18 FDG PET,
Brain metastases
Stereotactic radiation
Radio-necrosis
Pseudo-progression
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
dynamic [18-FDG PET] scan post stereotactic radiation for brain metastases
Description:
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.
Arm group label:
Observational
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 2024
Completion date:
August 2027
Lead sponsor:
Agency:
Lawson Health Research Institute
Agency class:
Other
Source:
Lawson Health Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06511323
