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Clinical Trials/NCT00760409
NCT00760409
Completed
Not Applicable

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

University of Michigan1 site in 1 country28 target enrollmentSeptember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Radiation Injury
Sponsor
University of Michigan
Enrollment
28
Locations
1
Primary Endpoint
Magnetic resonance imaging of treated brain tumors
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
June 1, 2015
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pia C Maly Sundgren, MD, PhD

Principal Investigator

University of Michigan

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

Outcomes

Primary Outcomes

Magnetic resonance imaging of treated brain tumors

Time Frame: 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

Study Sites (1)

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