NCT01017978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

2.4 years

First QC Date

November 20, 2009

Last Update Submit

December 2, 2015

Conditions

Soft Tissue Tumors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • MRI Scan

    3 weeks post start of chemo and end of chemo

Study Arms (1)

MRI Scan

OTHER

MRI scan of soft tissue tumor

Procedure: MRI Scan of soft tissue tumor

Interventions

MRI Scan of soft tissue tumorPROCEDURE

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

MRI Scan

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Soft Tissue Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Gary Luker, M.D.

    Universityof Michigan Health Systems

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2009

First Posted

November 23, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2011

Study Completion

April 1, 2012

Last Updated

December 4, 2015

Record last verified: 2015-12

Locations

US(1)