Evaluation of Brain Metastases Treated With Stereotactic Radiotherapy Using Dynamic [18F]FDG PET
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: dynamic [18-FDG PET] scan post stereotactic radiation for brain metastases.
- Who it may be relevant to
- Registry conditions: Brain Metastases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 test 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.
Primary outcome measures
- Diagnostic accuracy of dynamic PET [Time frame: 12-month follow-up.]
Secondary outcome measures (9)
- Clinical outcomes [Time frame: 24-month follow-up]
- Clinical outcomes [Time frame: 24-month follow-up]
- Clinical outcomes [Time frame: 24-month follow-up]
- Diagnostic imaging outcomes [Time frame: 24-month follow-up]
- Diagnostic imaging outcomes [Time frame: 24-month follow-up]
- Diagnostic imaging outcomes [Time frame: 24-month follow-up]
- Diagnostic imaging outcomes [Time frame: 24-month follow-up]
- Diagnostic imaging outcomes [Time frame: 24-month follow-up]
- Cost-effectiveness analysis [Time frame: 24-month follow-up]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06511323 · 124854