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 November 2012 by University of Michigan
Sponsor:
University of Michigan
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: November 30, 2012
Last verified: November 2012
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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 2013 (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.
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|
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: | November 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan:
|
recurrent tumor |
Additional relevant MeSH terms:
|
Brain Neoplasms Radiation Injuries Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site |
Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013