Clinical trial NCT00760409: Differentiating Recurrent Brain Tumor Versus Radiation Injury Using MRI
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiation Injury
Brain Tumor
Keywords: recurrent tumor
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-09-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have had a previous brain tumor and their physician has ordered a follow up MRI because your tumor may have returned.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Magnetic resonance imaging of treated brain tumors
timeFrame: 6mth. and 1 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Pia M Sundgren, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: