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Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01837563
Recruitment Status : Terminated
First Posted : April 23, 2013
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Locally Advanced Breast Cancer

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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 : September 2006
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837563


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center

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Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01837563    
Other Study ID Numbers: D0605
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases