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 : October 27, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Boas, PhD, Massachusetts General Hospital

January 9, 2014
January 10, 2014
October 27, 2016
March 2014
January 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02033486 on Archive Site
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Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)
Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)
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.
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Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Breast Cancer
Device: TOBI + DBT
Other Name: Diffuse Optical Tomography + digital breast tomosynthesis
Experimental: TOBI + DBT
TOBI + DBT of women presenting for breast imaging.
Intervention: Device: TOBI + DBT
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2019
January 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
30 Years to 80 Years   (Adult, Older Adult)
Contact: David Boas, PhD 617-724-0130
Contact: Mansi Saksena, MBBS 617-726-3093
United States
5R01CA142575 ( U.S. NIH Grant/Contract )
R01CA187595 ( U.S. NIH Grant/Contract )
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David Boas, PhD, Massachusetts General Hospital
Massachusetts General Hospital
National Cancer Institute (NCI)
Study Director: David A Boas, PhD Massachusetts General Hospital
Massachusetts General Hospital
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP