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.

Study Overview

• Status: Completed
• Conditions: Soft Tissue Tumors
• Intervention / Treatment: Procedure: MRI Scan of soft tissue tumor

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine if MRI imaging can accurately determine if a sarcoma (tumor)is responding to the type of chemotherapy being used.	To image and evaluate the size of the soft tissue tumor prior to chemotherapy treatment.	Baseline prior to chemo

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI Scan	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.	3 weeks post start of chemo and end of chemo

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Gary Luker, M.D., Universityof Michigan Health Systems

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: November 20, 2009
• First Submitted That Met QC Criteria: November 20, 2009
• First Posted (Estimate): November 23, 2009

Study Record Updates

• Last Update Posted (Estimate): December 4, 2015
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Soft Tissue Neoplasms
• Other Study ID Numbers: HUM 00023415