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Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT01837563
Collaborator
(none)
36
Enrollment
1
Location
108
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    36 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer
    Study Start Date :
    Sep 1, 2006
    Actual Primary Completion Date :
    Sep 1, 2015
    Actual Study Completion Date :
    Sep 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756

    Sponsors and Collaborators

    • Dartmouth-Hitchcock Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dartmouth-Hitchcock Medical Center
    ClinicalTrials.gov Identifier:
    NCT01837563
    Other Study ID Numbers:
    • D0605
    First Posted:
    Apr 23, 2013
    Last Update Posted:
    Sep 30, 2015
    Last Verified:
    Sep 1, 2015
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Sep 30, 2015