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Completed

NCT Number: NCT00760409

Differentiating Recurrent Brain Tumor Versus Radiation Injury Using MRI

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Sep 26, 2008
Registry last updated
Dec 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.