Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer

Terminated

• Conditions: Locally Advanced Breast Cancer

• Registration Number: NCT01837563
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2013-04-16
• Study First Submitted QC: 2013-04-18
• Study First Posted: 2013-04-23
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective Response	at baseline, at conclusion of treatment (up to 6 months)	Correlate changes in each imaging modality with objective response to therapy, as defined by conventional criteria (clinical exam and conventional imaging).

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States