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Quantitative MR Biomarkers for Sarcoma Treatment

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ClinicalTrials.gov Identifier: NCT01017978
Recruitment Status : Completed
First Posted : November 23, 2009
Last Update Posted : December 4, 2015
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Gary Luker M.D., University of Michigan

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

Condition or disease Intervention/treatment Phase
Soft Tissue Tumors Procedure: MRI Scan of soft tissue tumor Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Quantitative MR Biomarkers for Sarcoma Treatment
Study Start Date : July 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : April 2012

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    To image and evaluate the size of the soft tissue tumor prior to chemotherapy treatment.


Secondary Outcome Measures :
  1. MRI Scan [ Time Frame: 3 weeks post start of chemo and end of chemo ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Gary Luker M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01017978     History of Changes
Other Study ID Numbers: HUM 00023415
First Posted: November 23, 2009    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Sarcoma
Soft Tissue Neoplasms
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site