This trial is active, not recruiting.

Conditions radiation injury, brain tumor
Sponsor University of Michigan
Start date September 2008
End date January 2018
Trial size 50 participants
Trial identifier NCT00760409, HUM00050584


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective prospective
Radiation Injury Recurrent symptoms after radiation therapy of a brain tumor are not always the result of tumor recurrence but may represent radiation necrosis of the brain.
Symptoms are the result of actual tumor recurrence

Primary Outcomes

Magnetic resonance imaging of treated brain tumors
time frame: 6mth. and 1 year follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Prospective Study Differentiating Recurrent Brain Tumor Versus Radiation Injury Using Magnetic Resonance (MR) Spectroscopy, Diffusion Tensor Imaging and Diffusion Weighted Imaging on 3T(Tesla) MR Scanner
Principal investigator Pia M Sundgren, MD, Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by University of Michigan.