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Quantitative MR Biomarkers for Sarcoma Treatment

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Gary Luker M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT01017978
First received: November 20, 2009
Last updated: April 25, 2012
Last verified: April 2012
History of Changes
  Purpose

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


Condition Intervention
Soft Tissue Tumors
 Procedure: MRI Scan of soft tissue tumor

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Quantitative MR Biomarkers for Sarcoma Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • To determine if MRI imaging can accurately determine if a sarcoma (tumor)is responding to the type of chemotherapy being used. [ Time Frame: Baseline prior to chemo ] [ Designated as safety issue: No ]
    To image and evaluate the size of the soft tissue tumor prior to chemotherapy treatment.


Secondary Outcome Measures:
  • MRI Scan [ Time Frame: 3 weeks post start of chemo and end of chemo ] [ Designated as safety issue: No ]
    To evaluate the size of the soft tissue tumor after start of chemotherapy to determine if the chemo is having any notable effect on tumor prior to surgery.
Enrollment: 11
Study Start Date: July 2009
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MRI Scan
MRI scan of soft tissue tumor
 Procedure: MRI Scan of soft tissue tumor
MRI scan will be completed at baseline (prior to start of subject's clinically ordered chemotherapy treatments.

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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  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 ClinicalTrials.gov identifier: NCT01017978

Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institutes of Health (NIH)
Investigators
Principal Investigator: Gary Luker, M.D. Universityof Michigan Health Systems
  More Information

No publications provided

Responsible Party: Gary Luker M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01017978     History of Changes
Other Study ID Numbers: HUM 00023415
Study First Received: November 20, 2009
Last Updated: April 25, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 27, 2015