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Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)

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ClinicalTrials.gov Identifier: NCT02033486
Recruitment Status : Recruiting
First Posted : January 10, 2014
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mansi A Saksena, Massachusetts General Hospital

Brief Summary:
Screening for breast cancer improves early detection of aggressive cancers and has been shown to reduce breast cancer related mortality. Currently, mammography is the most effective way of detecting early stage, non palpable breast cancers. However, mammography only reveals the breast structure, and cannot say much about the breast physiological state. We propose Tomographic Optical Breast Imaging (TOBI) as an inexpensive, patient friendly technique that is non-invasive and does not use non-ionizing radiation. TOBI uses near infrared light and by measuring how such light passes through the breast, images of blood volume and hemoglobin oxygenation can be obtained. In this study, TOBI is combined with digital breast tomosynthesis (DBT, a form of 3D mammography) and our hypothesis is that the TOBI-DBT combined images can be used to diagnose breast cancer with significantly improved sensitivity and specificity compared to DBT alone.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: TOBI + DBT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)
Study Start Date : March 2014
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TOBI + DBT
TOBI + DBT of women presenting for breast imaging.
Device: TOBI + DBT
Other Name: Diffuse Optical Tomography + digital breast tomosynthesis




Primary Outcome Measures :
  1. Area under the curve for distinguishing benign vs malignant lesions [ Time Frame: 5 years ]
    We will compare optical-DBT vs DBT in terms of diagnosis specificity within the diagnostic population. We will base our analysis on total hemoglobin contrast which has been shown before by our group to be significantly different between malignant and benign lesions. By setting a threshold total hemoglobin ratio and comparing with the biopsy results, we can obtain a point on the receiver operating characteristic (ROC) for the selected parameter. By sliding the threshold over all possible values, we will render the full ROC curve. The area under the curve (AUC) will be calculated to compare with that of DBT.



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any adult female volunteers of any race or ethnic background, between the ages of 30 to 80, either

    • scheduled for a clinically indicated diagnostic mammogram or percutaneous biopsy.
    • presenting for breast cancer treatment

Exclusion Criteria:

  • Under 30 years old or over 80 years old
  • Is pregnant or thinks she may become pregnant.
  • Open wounds on breast
  • Breast implants
  • Any condition that impairs the ability to give informed consent

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): NCT02033486


Contacts
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Contact: Stefan Carp, PhD 617-643-2230 stefan.carp@mgh.harvard.edu
Contact: Mansi Saksena, MBBS 617-726-3093 msaksena@partners.org

Locations
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United States, Massachusetts
Stefan Carp Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Stefan Carp, PhD    617-643-2230    stefan.carp@mgh.harvard.edu   
Contact: Mansi Saksena, MBBS    617-726-3093    MSAKSENA@mgh.harvard.edu   
Principal Investigator: Mansi Saksena, MBBS         
Sub-Investigator: Stefan Carp, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Investigators
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Study Director: Stefan A Carp, PhD Massachusetts General Hospital
Principal Investigator: Mansi Saksena, MBBS Massachusetts General Hospital

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Responsible Party: Mansi A Saksena, Assistant Professor at Massachusetts General Hospital, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02033486     History of Changes
Other Study ID Numbers: 2013P000488
5R01CA142575 ( U.S. NIH Grant/Contract )
R01CA187595 ( U.S. NIH Grant/Contract )
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Keywords provided by Mansi A Saksena, Massachusetts General Hospital:
diffuse optical tomography
digital breast tomosynthesis
breast cancer
solid benign lesions
cysts
malignant lesions
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents