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.
Verified February 2014 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Pia C Maly Sundgren, MD, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT00760409
First received: September 24, 2008
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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.


Condition
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)
Groups/Cohorts
1
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.
2
Tumor recurrence

  Eligibility

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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760409

Contacts
Contact: Pia C Maly Sundgren, MD, PhD 734-763-3253 sundgren@umich.edu

Locations
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
Investigators
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
ClinicalTrials.gov 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:
Brain Neoplasms
Radiation Injuries
Wounds and Injuries
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 16, 2014