Differentiating Recurrent Brain Tumor Versus Radiation Injury Using MRI

Completed

• Conditions: Brain Tumor; Radiation Injury

• Registration Number: NCT00760409
• Lead Sponsor: University of Michigan

Brief Summary

The purpose of this study is to determine if certain MRI imaging sequences (pictures) are more helpful to the physicians in determining if a brain tumor has recurred or if the person has radiation injury following their treatment.

Detailed Description

After a patient has been treated for a brain tumor by radiation the area of the brain that has been treated changes in appearance. These changes in appearance can make it hard to determine if a brain tumor has come back at the same site or if it is radiation injury. The purpose of this study is to determine if certain MRI imaging sequences (pictures) are more helpful to the physicians in determining if the tumor has come back or if it is radiation injury.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-26
• Primary Completion: 2015-06-01
• Study Completion: 2015-06-01
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-20
• Last Update Posted: 2017-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Patients previously treated with radiation therapy (including radiosurgery), with or without previous surgery or chemotherapy, with a new contrast enhancing lesion(s) with the size of 1 cm or more on conventional brain MRI examination are eligible
• Patients must have a previously histological confirmed brain tumor
• Patients must be 18 years of age or older
• Patients must sign a study-specific consent form approved by the Institutional Review Board of the University of Michigan indicating prior to study entry

Exclusion Criteria

• Pregnant woman
• For the purpose of this radiological study and in collecting data from the patient but not from receiving the MR Spectroscopy if it is clinically indicated.
• Patients unable to undergo MRI imaging because of non-compatible devices such as cardiac pacemakers, other implanted electronic devices, or foreign body in the eye
• Also patients with metallic prostheses, or ferromagnetic prostheses (e.g. pins in artificial joints and surgical pins/clips in the face or skull region), or patients with braces since these devices may cause metal artifacts which may obscure the images and result in artifacts on the MR spectroscopy.
• Prisoners

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Magnetic resonance imaging of treated brain tumors	6mth. and 1 year follow-up	The purpose of this study is to determine if certain MRI imaging sequences are more helpful to the physicians in determining if the tumor has come back or if it is radiation injury

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States