Testing New Method of Analyzing MR Images

NCT ID: NCT00630318

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Breast Abnormalities

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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MRI

15-20 minutes MR imaging

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan E. Clare, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Methodist Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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0710-67

Identifier Type: -

Identifier Source: org_study_id

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