Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging

Phase 1

Completed

• Conditions: Brain Metastases
• Interventions: Device: dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging

• Registration Number: NCT02311556
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-07
• Study First Submitted: 2014-12-04
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-08
• Primary Completion: 2016-07-01
• Study Completion: 2016-12-16
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DSC-PMR	dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging	DSC-PMR (dynamic susceptibility-weighted contrast- enhanced perfusion magnetic resonance imaging) at baseline (screening or time of radiosurgery) and after radiosurgery

Primary Outcome Measures

Name	Time	Method
Time to local progression of each treated and evaluable brain metastasis	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 Outcome Measures

Name	Time	Method
Radiation necrosis	Up to 1 year	Radiation necrosis will be defined by pathology, when available. When no pathology is available, clinical diagnosis based on clinical course and management will be used.
Complete response	Up to 1 year	Complete response = no residue enhancing lesion on MRI
Elsewhere brain failure	Up to 1 year	Elsewhere brain failure = appearance of brain metastases outside of the prior radiosurgery region which can be diagnosed radiographically and does not required require pathological confirmation.
Clinical deterioration	Up to 1 year	Clinical deterioration will be assessed based on the Karnofsky Performance scale (KPS).; * 100=Normal no complaints; no evidence of disease.; * 90=Able to carry on normal activity; minor signs or symptoms of disease.; * 80=Normal activity with effort; some signs or symptoms of disease.; * 70=Cares for self; unable to carry on normal activity or to do active work.; * 60=Requires occasional assistance, but is able to care for most of his personal needs.; * 50=Requires considerable assistance and frequent medical care.; * 40=Disabled; requires special care and assistance.; * 30=Severely disabled; hospital admission is indicated although death not imminent.; * 20=Very sick; hospital admission necessary; active supportive treatment necessary.; * 10=Moribund; fatal processes progressing rapidly.; * 0=Dead

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States