Status:
COMPLETED
Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging
Lead Sponsor:
Washington University School of Medicine
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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/1.73m2.
- Patient must not have melanoma.
- Patient must not have hemorrhagic lesions.
Key Trial Info
Start Date :
May 7 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2016
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT02311556
Start Date
May 7 2013
End Date
December 16 2016
Last Update
February 24 2017
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110