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Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer

NCT ID: NCT01837563

Last Updated: 2015-09-30

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

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2015-09-30

Brief Summary

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The purpose of this study is to determine whether four new alternative imaging methods can be used to follow the response of breast cancer to the treatment patients are being given. These methods produce an image of the inside of the breast so that doctors can better decide whether breast cancer is responding to therapy. An important part of the study is to examine the same person with all methods in order to directly compare results. The four methods are: MRI Elasticity Imaging (abbreviated MRE), Electrical Impedance Spectroscopy (abbreviated EIS), Microwave Imaging and Spectroscopy (abbreviated MIS), Near Infrared Spectroscopy (abbreviated NIR). In addition to the experimental imaging methods, patients may also undergo a contrast-enhanced MRI, and/or additional mammography, which will help researchers compare the experimental methods. These additional examinations are accepted diagnostic procedures; they are not experimental. Some participants will have one or both of these additional examinations if clinically indicated.

Detailed Description

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Conditions

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Locally Advanced Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Locally advanced breast cancer, with or without metastatic disease
2. Patient to receive systemic therapy
3. Breast size and epithelial integrity adequate to allow alternate imaging exams.
4. Patient able to provide written informed consent.
5. No serious associated psychiatric illness
6. Age ≥ 18 years old

Exclusion Criteria

1. Cardiac pacemaker
2. Any implanted electronic device
3. Severe claustrophobia
4. Allergy to the MRI contrast agent gadolinium
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Other Identifiers

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D0605

Identifier Type: -

Identifier Source: org_study_id