Quantitative MR Biomarkers for Sarcoma Treatment

This study has been completed.
Sponsor:
Collaborator:
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

November 20, 2009
April 25, 2012
July 2009
December 2011   (final data collection date for primary outcome measure)
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.
To determine if MRI imaging can accurately determine if a sarcoma (tumor)is responding to the type of chemotherapy being used. [ Time Frame: MRI scan after 3 & 12 weeks of treatment. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01017978 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
Quantitative MR Biomarkers for Sarcoma Treatment
Quantitative MR Biomarkers for Sarcoma Treatment

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

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Soft Tissue Tumors
Procedure: MRI Scan of soft tissue tumor
MRI scan will be completed at baseline (prior to start of subject's clinically ordered chemotherapy treatments.
MRI Scan
MRI scan of soft tissue tumor
Intervention: Procedure: MRI Scan of soft tissue tumor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
April 2012
December 2011   (final data collection date for primary outcome measure)

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.

    -

Both
3 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01017978
HUM 00023415
Yes
Gary Luker M.D., University of Michigan
University of Michigan
National Institutes of Health (NIH)
Principal Investigator: Gary Luker, M.D. Universityof Michigan Health Systems
University of Michigan
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP