Back to resultsTesting New Method of Analyzing MR Images
Primary Purpose
Breast Abnormalities
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Abnormalities focused on measuring MR scanning
Eligibility 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
Sites / Locations
- Methodist Hospital
Outcomes
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00630318
Brief Title
Testing New Method of Analyzing MR Images
Official Title
Imaging Protocol Design for Anti-Angiogenesis Tracking With MRI
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Unable to accrue enough subjects to analyze data.
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Preliminary imaging study to test for future use of this MRI-imaging for evaluating anti-angiogenesis treatment.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Abnormalities
Keywords
MR scanning
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
15-20 minutes MR imaging
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan E. Clare, MD, Ph.D.
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Testing New Method of Analyzing MR Images
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