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Completed

NCT Number: NCT01017978

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.

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Key information

Conditions

Soft Tissue Tumors Neoplasms Neoplasms by Site Soft Tissue Neoplasms

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biopsy proven primary bone or soft tissue tumor
  • No previous treatment for this malignancy
  • Will be given chemotherapy before having surgery or radiation on the tumor.
  • Are able to undergo a MRI examination
  • If your tumor measures at least 1/2 inch in length.

Exclusion criteria

  • Younger than 3 yrs. of age or need general anesthesia(sedation that puts you to sleep) to have a MRI performed.
  • History of Renal Failure
  • 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.
  • 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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Treatment and study plan

MRI Scan of soft tissue tumor

Procedure

MRI scan will be completed at baseline (prior to start of subject's clinically ordered chemotherapy treatments.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Nov 23, 2009
Registry last updated
Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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