Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer

NCT01837563 | Terminated DMC

• 1 other identifier: D0605
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response

  Correlate changes in each imaging modality with objective response to therapy, as defined by conventional criteria (clinical exam and conventional imaging).

  at baseline, at conclusion of treatment (up to 6 months)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with locally-advanced breast cancer, with or without metastatic disease, meeting inclusion criteria (and giving informed consent for participation) receiving systemic therapy at DHMC will be enrolled. Breast size and epithelial integrity of the skin surface can limit the ability to deliver effective imaging exams, adn these individual characteristics need be determined in each individual patient. Women with pacemakers or other implanted electronic devices will not be allowed into the study because of potential for electrical interference with proper operation during an imaging session.

You may qualify if:

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

You may not qualify if:

• Cardiac pacemaker
• Any implanted electronic device
• Severe claustrophobia
• Allergy to the MRI contrast agent gadolinium

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 23, 2013
• Study Start: September 1, 2006
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 30, 2015

Record last verified: 2015-09

Locations

US (1)