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 enrollmentMay 7, 2013

ConditionsBrain Metastases

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Brain Metastases
Sponsor: Washington University School of Medicine
Enrollment: 23
Locations: 1
Primary Endpoint: Time to local progression of each treated and evaluable brain metastasis
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

May 7, 2013

End Date

December 16, 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Washington University School of Medicine

Responsible Party

Sponsor

Eligibility Criteria

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.