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

Metastatic Brain Tumor Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01908179
• Other study ID #: SRS - Mets
• Status: Recruiting
• Phase: N/A
• First received: July 23, 2013
• Last updated: July 24, 2013
• Start date: January 2013

Study information

• Verified date: July 2013
• Source: Swedish Medical Center
• Contact: Tracie Granger
• Phone: 206-215-2466
• Email: tracie.granger[@]swedish.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Neoplasms
• Metastatic Brain Tumor

Locations

Country	Name	City	State
United States	Swedish Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative measures of overall tumor volume will be performed for each subject at the time of SRS		At the time of SRS	No
Primary	Quantitative measures of tumor number will be performed for each subject at the time of SRS		At the time of SRS	No
Primary	Overall survival will be measured for each subject (in weeks from SRS to death)		Post-SRS	No
Secondary	Measures of ADC, rCBV, MTT and ktrans will be performed for each treated tumor at treatment and at 6 months following SRS		6 months post SRS	No
Secondary	Time to progression (in weeks) will be measured for each treated tumor		Post-SRS	No
Secondary	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		12 months post-SRS	No