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An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection


N/A
18 Years
N/A
Open (Enrolling)
Both
Brain Mass

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Trial Information

An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection


Inclusion Criteria:



- Male or female, age 18 years or older of any racial or ethnic group

- Spanish-speaking patients will be eligible

- Pre-operative brain MR imaging suggestive of a brain tumor

- Patient able and willing to provide informed consent

- Karnofsky Performance status > 70%

- Negative serum pregnancy test or child bearing potential terminated by surgery,
radiation, menopause or current use of two approved methods of birth control

Exclusion Criteria:

- Patient unable to provide informed consent

- Karnofsky Performance status < 70%

- Patients who are claustrophobic or have other contraindications to MRI, such as
implanted pacemaker device vascular clips, surgical clips, prosthetic valves,
pacemakers, otologic implants

- NYHA class III and IV congestive heart failure

- Psychiatric or addictive disorders that preclude obtaining informed consent

- Unstable angina

- Pregnant or lactating women

- Women of childbearing potential who refuse a pregnancy test (performed during
screening)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

metabolic phenotype correlation to clinical endpoints

Outcome Description:

To correlate the metabolic phenotype obtained from histopathological diagnosis with the clinical endpoints of time to tumor progression and overall survival during the 5 years of patient follow-up

Outcome Time Frame:

at end of follow-up period- between days 1-14

Safety Issue:

No

Principal Investigator

Elizabeth Maher, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas

Authority:

United States: Institutional Review Board

Study ID:

SCCC-03F09

NCT ID:

NCT01668082

Start Date:

May 2010

Completion Date:

July 2015

Related Keywords:

  • Brain Mass
  • Patients with newly identified brain mass
  • Brain Neoplasms

Name

Location

University of Texas SouthwesternDallas, Texas  75390