Testing New Method of Analyzing MR Images

This study has been terminated.
(Unable to accrue enough subjects to analyze data.)
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00630318
First received: February 28, 2008
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention
Breast Abnormalities
Device: MRI

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Imaging Protocol Design for Anti-Angiogenesis Tracking With MRI

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: March 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: MRI
    15-20 minutes MR imaging
    Other Name: MRI
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00630318     History of Changes
Other Study ID Numbers: 0710-67
Study First Received: February 28, 2008
Last Updated: March 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
MR scanning

ClinicalTrials.gov processed this record on October 23, 2014