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Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02033486
Recruitment Status : Recruiting
First Posted : January 10, 2014
Last Update Posted : April 18, 2019
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.

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT02033486

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Contact: Stefan Carp, PhD 617-643-2230
Contact: Mansi Saksena, MBBS 617-726-3093

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United States, Massachusetts
Stefan Carp Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Stefan Carp, PhD    617-643-2230   
Contact: Mansi Saksena, MBBS    617-726-3093   
Principal Investigator: Mansi Saksena, MBBS         
Sub-Investigator: Stefan Carp, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
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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 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
malignant lesions
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Anti-Bacterial Agents
Anti-Infective Agents