Quantitative MR Biomarkers for Sarcoma Treatment

Soft Tissue Tumors Clinical Trial

Official title:

Quantitative MR Biomarkers for Sarcoma Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01017978
• Other study ID #: HUM 00023415
• Status: Completed
• Phase: N/A
• First received: November 20, 2009
• Last updated: December 2, 2015
• Start date: July 2009
• Est. completion date: April 2012

Study information

• Verified date: December 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Soft Tissue Neoplasms
• Soft Tissue Tumors

Intervention

Procedure:
• MRI Scan of soft tissue tumor
MRI scan will be completed at baseline (prior to start of subject's clinically ordered chemotherapy treatments.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No