Quantitative MR Biomarkers for Sarcoma Treatment

Not Applicable

Completed

• Conditions: Soft Tissue Tumors
• Interventions: Procedure: MRI Scan of soft tissue tumor

• Registration Number: NCT01017978
• Lead Sponsor: University of Michigan

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.

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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-11-20
• Study First Submitted QC: 2009-11-20
• Study First Posted: 2009-11-23
• Primary Completion: 2011-12
• Study Completion: 2012-04
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI Scan	MRI Scan of soft tissue tumor	MRI scan of soft tissue tumor

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
MRI Scan	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.

Trial Locations

Locations (1)

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States