NCT02311556
Completed
Phase 1
Assessment of Early Treatment Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging
Washington University School of Medicine1 site in 1 country23 target enrollmentStarted: May 7, 2013Last updated:
ConditionsBrain Metastases
Overview
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Time to local progression of each treated and evaluable brain metastasis
Overview
Brief Summary
This study is designed to evaluate whether advanced magnetic resonance imaging (MRI) techniques such as dynamic susceptibility-weighted contrast-enhanced perfusion MRI may be used to predict treatment response of brain metastasis after radiosurgery.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient must have newly diagnosed brain metastases visible on brain MRI. A biopsy of the lesion is not required as long as the patient has a biopsy-proven malignancy elsewhere and a clinician deems the lesion to be metastatic.
- •At least one brain metastasis must be ≥ 1cm to allow adequate quantitative imaging measurement for DSC-PMR.
- •Patient must be clinically eligible for and elect to be treated with GK alone without WBRT.
- •Patient must be ≥ 18 years of age.
- •Patient must have Karnofsky Performance Status (KPS) of at least 60
- •Patient may be part of other clinical trials (as long as no other local treatments beyond GK such as WBRT or other local therapy are indicated to the brain) or imaging studies.
- •Patient or legally authorized representative must be able to understand and willing to sign a written informed consent document.
Exclusion Criteria
- •Patient must not have any medical contraindications to MRI (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis).
- •Patient must not be pregnant or breastfeeding.
- •Patient must not have an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m
- •Patient must not have melanoma.
- •Patient must not have hemorrhagic lesions.
Outcomes
Primary Outcomes
Time to local progression of each treated and evaluable brain metastasis
Time Frame: At time of radiosurgery and after radiosurgery (approximately 1 week)
Tumor perfusion on DSC-PMR will be used as predictor for time to local tumor progression.
Secondary Outcomes
- Radiation necrosis(Up to 1 year)
- Complete response(Up to 1 year)
- Elsewhere brain failure(Up to 1 year)
- Clinical deterioration(Up to 1 year)
Investigators
Study Sites (1)
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