Overview

This trial is active, not recruiting.

Condition brain metastases
Treatment dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging
Phase phase 0
Sponsor Washington University School of Medicine
Start date May 2013
End date July 2016
Trial size 25 participants
Trial identifier NCT02311556, 201302018

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
DSC-PMR (dynamic susceptibility-weighted contrast- enhanced perfusion magnetic resonance imaging) at baseline (screening or time of radiosurgery) and after radiosurgery
dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging DSC-PMR

Primary Outcomes

Measure
Time to local progression of each treated and evaluable brain metastasis
time frame: At time of radiosurgery and after radiosurgery (approximately 1 week)

Secondary Outcomes

Measure
Radiation necrosis
time frame: Up to 1 year
Complete response
time frame: Up to 1 year
Elsewhere brain failure
time frame: Up to 1 year
Clinical deterioration
time frame: Up to 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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/1.73m2. - Patient must not have melanoma. - Patient must not have hemorrhagic lesions.

Additional Information

Official title Assessment of Early Treatment Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging
Principal investigator Jiayi Huang, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.
Location data was received from the National Cancer Institute and was last updated in August 2016.