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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Michigan
Information provided by (Responsible Party):
Pia C Maly Sundgren, MD, PhD, University of Michigan Identifier:
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.

Radiation Injury
Brain Tumor

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Magnetic resonance imaging of treated brain tumors [ Time Frame: 6mth. and 1 year follow-up ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 50
Study Start Date: September 2008
Estimated Study Completion Date: September 2014
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.
Tumor recurrence


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.


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
  Contacts and Locations
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 identifier: NCT00760409

Contact: Pia C Maly Sundgren, MD, PhD 734-763-3253

United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Pia C Maly Sundgren, M, PhD         
Sponsors and Collaborators
University of Michigan
Principal Investigator: Pia M Sundgren, MD, Ph.D University of Michigan Hospital
  More Information

No publications provided

Responsible Party: Pia C Maly Sundgren, MD, PhD, Principal Investigator, University of Michigan Identifier: NCT00760409     History of Changes
Other Study ID Numbers: HUM00050584
Study First Received: September 24, 2008
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
recurrent tumor

Additional relevant MeSH terms:
Radiation Injuries
Wounds and Injuries processed this record on March 03, 2015