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Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)

This study is currently recruiting participants.
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Verified October 2016 by David Boas, PhD, Massachusetts General Hospital
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Boas, PhD, Massachusetts General Hospital Identifier:
First received: January 9, 2014
Last updated: October 26, 2016
Last verified: October 2016
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 Intervention
Breast Cancer Device: TOBI + DBT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)

Resource links provided by NLM:

Further study details as provided by David Boas, PhD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 375
Study Start Date: March 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TOBI + DBT
TOBI + DBT of women presenting for breast imaging.
Device: TOBI + DBT
Other Name: Diffuse Optical Tomography + digital breast tomosynthesis


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02033486

Contact: David Boas, PhD 617-724-0130
Contact: Mansi Saksena, MBBS 617-726-3093

United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: David A Boas, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Study Director: David A Boas, PhD Massachusetts General Hospital
  More Information

Responsible Party: David Boas, PhD, Professor of Radiology, 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 )
Study First Received: January 9, 2014
Last Updated: October 26, 2016

Keywords provided by David Boas, PhD, Massachusetts General Hospital:
diffuse optical tomography
digital breast tomosynthesis
breast cancer
solid benign lesions
malignant lesions processed this record on August 18, 2017