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Quantitative MR Biomarkers for Sarcoma Treatment

NCT ID: NCT01017978

Last Updated: 2015-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-04-30

Brief Summary

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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

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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.

Conditions

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Soft Tissue Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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MRI Scan

MRI scan of soft tissue tumor

Group Type OTHER

MRI Scan of soft tissue tumor

Intervention Type PROCEDURE

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

Interventions

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MRI Scan of soft tissue tumor

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

Intervention Type PROCEDURE

Eligibility Criteria

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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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Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Gary Luker M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gary Luker, M.D.

Role: PRINCIPAL_INVESTIGATOR

Universityof Michigan Health Systems

Locations

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University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM 00023415

Identifier Type: -

Identifier Source: org_study_id