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Clinical Trials/NCT01837563
NCT01837563
Terminated
Not Applicable

Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer

Dartmouth-Hitchcock Medical Center1 site in 1 country36 target enrollmentSeptember 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Locally Advanced Breast Cancer
Sponsor
Dartmouth-Hitchcock Medical Center
Enrollment
36
Locations
1
Primary Endpoint
Objective Response
Status
Terminated
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2006
End Date
September 2015
Last Updated
10 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Objective Response

Time Frame: 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).

Study Sites (1)

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