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

NCT02311556 | Completed Phase 1 DMC FDA Device

• 1 other identifier: 201302018
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Radiation necrosis

  Up to 1 year

• Complete response

  Up to 1 year

• Elsewhere brain failure

  Up to 1 year

• Clinical deterioration

  Up to 1 year

Study Arms (1)

DSC-PMR

EXPERIMENTAL

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

Interventions

dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging DEVICE

Also known as: DSC-PMR

DSC-PMR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jiayi Huang, M.D.

  Washington University of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 8, 2014
• Study Start: May 7, 2013
• Primary Completion: July 1, 2016
• Study Completion: December 16, 2016
• Last Updated: February 24, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)