Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer

Locally Advanced Breast Cancer Clinical Trial

Official title:

Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01837563
• Other study ID #: D0605
• Status: Terminated
• Phase: N/A
• First received: April 16, 2013
• Last updated: September 28, 2015
• Start date: September 2006
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Locally Advanced Breast Cancer

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No