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

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

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.

Study Overview

• Status: Completed
• Conditions: Brain Metastases
• Intervention / Treatment: Device: dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DSC-PMR; DSC-PMR (dynamic susceptibility-weighted contrast- enhanced perfusion magnetic resonance imaging) at baseline (screening or time of radiosurgery) and after radiosurgery	Device: dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging; Other Names: DSC-PMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to local progression of each treated and evaluable brain metastasis	Tumor perfusion on DSC-PMR will be used as predictor for time to local tumor progression.	At time of radiosurgery and after radiosurgery (approximately 1 week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation necrosis	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.	Up to 1 year
Complete response	Complete response = no residue enhancing lesion on MRI	Up to 1 year
Elsewhere brain failure	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.	Up to 1 year
Clinical deterioration	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	Up to 1 year

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Jiayi Huang, M.D., Washington University of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2013
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): December 16, 2016

Study Registration Dates

• First Submitted: December 4, 2014
• First Submitted That Met QC Criteria: December 4, 2014
• First Posted (Estimate): December 8, 2014

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: 201302018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No