High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors

Brain Tumor Clinical Trial

Official title:

High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035852
• Other study ID #: STU 062010-160
• Secondary ID: 1R01CA154843-01A
• Status: Completed
• Start date: August 28, 2009
• Est. completion date: April 20, 2018

Study information

• Verified date: November 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: April 20, 2018
• Est. primary completion date: April 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

Other:
• MRI
3T MRI vs. 7T MRI

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Benefit of 7T MR imaging	1. To determine the benefit of 7T MR imaging in brain tumor patients with regard to the improvement in resolution, as measured by the area of T2 FLAIR signal abnormality and the ability to detect abnormalities in vascular integrity. The benefit will be determined at a single time point as well as longitudinally for each patient at 6 month intervals.	Baseline and 6 month intervals after baseline
Secondary	Vascular Integrity	To determine if changes in vascular integrity at 7T can be correlated with tumor progression or transformation to high grade in patients with low grade gliomas.	Every 6 months, up to 12 months.