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Testing New Method of Analyzing MR Images

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ClinicalTrials.gov Identifier: NCT00630318
Recruitment Status : Terminated (Unable to accrue enough subjects to analyze data.)
First Posted : March 7, 2008
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

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
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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
Criteria

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00630318


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

Responsible Party: Indiana University
ClinicalTrials.gov 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