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Quantitative MR Biomarkers for Sarcoma Treatment


N/A
3 Years
N/A
Not Enrolling
Both
Soft Tissue Tumors

Thank you

Trial Information

Quantitative MR Biomarkers for Sarcoma Treatment


The purpose of this study is to determine if MRI imaging can be used to accurately determine
if a sarcoma is responding to the type of chemotherapy being used or if it is ineffective
early on in the treatment; instead of finding this out 2-3 months later. If it is
determined that MRI can accurately diagnose tumor response, medications can be switched
early on potentially improv8ing the patients'chances of recovery.


Inclusion Criteria:



1. Biopsy proven primary bone or soft tissue tumor

2. No previous treatment for this malignancy

3. Will be given chemotherapy before having surgery or radiation on the tumor.

4. Are able to undergo a MRI examination

5. If your tumor measures at least 1/2 inch in length.

Exclusion Criteria:

1. Younger than 3 yrs. of age or need general anesthesia(sedation that puts you to
sleep) to have a MRI performed.

2. History of Renal Failure

3. Are not able to have a MRI performed for any reason such as you have a pacemaker or
other implanted device that may malfunction or move because of the magnetic field
inside the MRI room and scanner.

4. Have any history of an allergic reaction to gadolinium based contrast agents (a
medication injected in a vein that helps create clearer MRI images.

-

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

To determine if MRI imaging can accurately determine if a sarcoma (tumor)is responding to the type of chemotherapy being used.

Outcome Description:

To image and evaluate the size of the soft tissue tumor prior to chemotherapy treatment.

Outcome Time Frame:

Baseline prior to chemo

Safety Issue:

No

Principal Investigator

Gary Luker, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universityof Michigan Health Systems

Authority:

United States: Institutional Review Board

Study ID:

HUM 00023415

NCT ID:

NCT01017978

Start Date:

July 2009

Completion Date:

April 2012

Related Keywords:

  • Soft Tissue Tumors
  • Soft Tissue Neoplasms
  • Sarcoma

Name

Location
University of Michigan Health System Ann Arbor, Michigan