Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)

Last updated: April 16, 2019
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT02033486
2013P000488
5R01CA142575
R01CA187595
  • Ages 30-80
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • scheduled for a clinically indicated diagnostic mammogram or percutaneous biopsy.

  • presenting for breast cancer treatment

Exclusion

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

Study Design

Total Participants: 375
Study Start date:
March 01, 2014
Estimated Completion Date:
March 31, 2021

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Stefan Carp

    Charlestown, Massachusetts 02129
    United States

    Active - Recruiting

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