Testing New Method of Analyzing MR Images

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00630318
Recruitment Status : Terminated (Unable to accrue enough subjects to analyze data.)
First Posted : March 7, 2008
Last Update Posted : January 12, 2017
Information provided by (Responsible Party):
Indiana University

Brief Summary:
Preliminary imaging study to test for future use of this MRI-imaging for evaluating anti-angiogenesis treatment.

Condition or disease Intervention/treatment Phase
Breast Abnormalities Device: MRI Phase 1

Detailed Description:

The purpose of this study is to develop and evaluate new MR imaging techniques and protocols for non-invasive monitoring of anti-angiogenesis treatment of breast cancer. This feasibility study is a preliminary imaging study to test this imaging protocol on subjects already undergoing MR for clinical purposes.

The specific objective of this research study is to develop and validate both MRI and functional MRI data acquisition methods, task paradigms, and post-processing techniques to ensure reliability of results.

The information derived from this research is intended to be applied to a future study of subjects undergoing experimental anti-angiogenesis drug therapy.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging Protocol Design for Anti-Angiogenesis Tracking With MRI
Study Start Date : March 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Device: MRI
    15-20 minutes MR imaging

Primary Outcome Measures :
  1. To provide preliminary data for a larger study that this type of imaging can be used to monitor the effectiveness of anti-angiogenic therapy. [ Time Frame: After analysis of images ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Females
  • Age 18 years or greater
  • Undergoing breast MRI exam

Exclusion Criteria:

  • Pregnancy
  • Contraindication for MRI on standard screening checklist for clinically indicated examinations (i.e. metal devices/implants; history of claustrophobia)
  • History/presence of any of the following to the breast: injury; breast implant; surgical or interventional procedure; clinically significant abnormality

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00630318

United States, Indiana
Methodist Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Principal Investigator: Susan E. Clare, MD, Ph.D. Indiana University

Responsible Party: Indiana University Identifier: NCT00630318     History of Changes
Other Study ID Numbers: 0710-67
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by Indiana University:
MR scanning