Prospective Study Differentiating Recurrent Brain Tumor Versus Radiation Injury Using MR Spectroscopy, Diffusion Tensor Imaging and Diffusion Weighted Imaging on 3T MR Scanner

This study is currently recruiting participants.

Verified by University of Michigan, September 2008

Sponsored by:	University of Michigan
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00760409

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 Tumor

MedlinePlus related topics: Brain Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective

Further study details as provided by University of Michigan:

Primary Outcome Measures:

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 [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:

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

Patiets 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 IRB 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 artefacts which may obscure the images and result in artefacts 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

More Information

Responsible Party:	( Pia C. Maly Sundgren MD, PhD )
Study ID Numbers:	2005-0327
Study First Received:	September 24, 2008
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00760409
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan:

recurrent tumor

Study placed in the following topic categories:

Brain Neoplasms
Wounds and Injuries
Disorders of Environmental Origin
Recurrence
Radiation Injuries

ClinicalTrials.gov processed this record on January 14, 2009