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
Verified February 2014 by University of Michigan
Information provided by (Responsible Party):
Pia C Maly Sundgren, MD, PhD, University of Michigan
First received: September 24, 2008
Last updated: February 11, 2014
Last verified: February 2014
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.
||Time Perspective: Prospective
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients that have had a previous brain tumor and their physician has ordered a follow up MRI because your tumor may have returned.
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760409
|University of Michigan
|Ann Arbor, Michigan, United States, 48109 |
|Contact: Pia C Maly Sundgren, M, PhD |
University of Michigan
||Pia M Sundgren, MD, Ph.D
||University of Michigan Hospital
No publications provided
||Pia C Maly Sundgren, MD, PhD, Principal Investigator, University of Michigan
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 24, 2008
||February 11, 2014
||United States: Institutional Review Board
Keywords provided by University of Michigan:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms
Wounds and Injuries