Markers of Prognosis and Response to Therapy in Patients With Metastatic Brain Tumors Undergoing Stereotactic Radiosurgery (SRS)

July 24, 2013 updated by: Swedish Medical Center
This registry study will evaluate patients with metastatic brain tumors undergoing, or having undergone, stereotactic radiosurgery (SRS) at Swedish Medical Center. Clinical outcomes will be evaluated at the 3, 6 and 12-month time points. Clinical data, SRS treatment data, and imaging data (including anatomic and advanced imaging sequences obtained prior to and serially following SRS) will be archived in an online informatics platform, specifically a metastatic brain tumor registry known as the Comprehensive Neuro-oncology Data Repository for Metastatic Tumors (CONDR - Mets).

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center
        • Contact:
        • Principal Investigator:
          • Sarah Fouke, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with metastatic brain tumors undergoing, or have undergone, sterotactic radiosurgery (SRS)

Description

Inclusion Criteria:

  • Adult patients (>18 yo) with a pathological diagnosis of metastatic brain cancer
  • Participants must have >4 tumors felt to require stereotactic radiosurgery
  • Karnofsky scale of > 70 at the time of initial treatment
  • Age < 80

Exclusion Criteria:

  • Karnofsky scale <70
  • Age > 80
  • Inability to undergo MR imaging studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantitative measures of overall tumor volume will be performed for each subject at the time of SRS
Time Frame: At the time of SRS
At the time of SRS
Quantitative measures of tumor number will be performed for each subject at the time of SRS
Time Frame: At the time of SRS
At the time of SRS
Overall survival will be measured for each subject (in weeks from SRS to death)
Time Frame: Post-SRS
Post-SRS

Secondary Outcome Measures

Outcome Measure
Time Frame
Measures of ADC, rCBV, MTT and ktrans will be performed for each treated tumor at treatment and at 6 months following SRS
Time Frame: 6 months post SRS
6 months post SRS
Time to progression (in weeks) will be measured for each treated tumor
Time Frame: Post-SRS
Post-SRS
Diagnosis of progression or radiation necrosis (made on clinical reflection at study's end) will be determined for tumors where diagnosis is in question at 6 and 12 months after SRS
Time Frame: 12 months post-SRS
12 months post-SRS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swedish Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

July 1, 2015

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

July 24, 2013

First Posted (Estimate)

July 25, 2013

Study Record Updates

Last Update Posted (Estimate)

July 25, 2013

Last Update Submitted That Met QC Criteria

July 24, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRS - Mets

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Brain Tumor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe