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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-07

Study Completion Date

2016-12-16

Brief Summary

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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.

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RECRUITING PHASE4

Detailed Description

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Conditions

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Brain Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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DSC-PMR

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

Group Type EXPERIMENTAL

dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging

Intervention Type DEVICE

Interventions

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dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging

Intervention Type DEVICE

Other Intervention Names

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DSC-PMR

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No