High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors

NCT ID: NCT02035852

Last Updated: 2019-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

184 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-28

Study Completion Date

2018-04-20

Brief Summary

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The study will compare two different size MRI's of a brain tumor.

Detailed Description

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The study is designed to directly compare the MR images of a brain tumor obtained on the 3T and then 7T MRI in approximately 150 patients followed serially with MR imaging to evaluate for tumor progression.

Conditions

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Brain Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult Gilomas

MRI

Intervention Type OTHER

3T MRI vs. 7T MRI

Interventions

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MRI

3T MRI vs. 7T MRI

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female, age 18 years or older
* Patient must meet at least one of the four following criteria regarding brain tumor diagnosis:
* Histological diagnosis of a brain tumor
* Histological diagnosis of systemic cancer and brain MR imaging suggestive of metastatic disease to the brain
* Pre-operative brain MR imaging suggestive of a brain tumor
* Radiographic diagnosis of brain tumor in an inoperable location (e.g., brainstem)
* Patient able and willing to provide informed consent
* Karnofsky Performance status \> 70%
* Life expectancy greater than 3 months
* Negative serum or urine pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control
* Patients who are excluded from 7T MR imaging because of titanium implants that are not yet established to be safe at 7T remain eligible for the imaging at 3T \* Spanish speaking participants will be enrolled for this study

Exclusion Criteria

* Body weight \>137 Kg (300 lbs)
* 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
* Sexually active patients of childbearing potential not using a reliable contraceptive method
* Pregnant or lactating women
* Women of childbearing potential who refuse a pregnancy test (performed during screening)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Maher, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

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UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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1R01CA154843-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU 062010-160

Identifier Type: -

Identifier Source: org_study_id

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