Testing New Method of Analyzing MR Images

Breast Abnormalities Clinical Trial

Official title:

Imaging Protocol Design for Anti-Angiogenesis Tracking With MRI

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00630318
• Other study ID #: 0710-67
• Status: Terminated
• Phase: Phase 1
• First received: February 28, 2008
• Last updated: January 11, 2017
• Start date: March 2008
• Est. completion date: July 2010

Study information

• Verified date: January 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Abnormalities

Intervention

Device:
• MRI
15-20 minutes MR imaging

Locations

Country	Name	City	State
United States	Methodist Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide preliminary data for a larger study that this type of imaging can be used to monitor the effectiveness of anti-angiogenic therapy.		After analysis of images	No