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Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)

Mass General Brigham logo

Mass General Brigham

Status

Unknown

Conditions

Breast Cancer

Treatments

Device: TOBI + DBT

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02033486
2013P000488
R01CA187595 (U.S. NIH Grant/Contract)
5R01CA142575 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

375 estimated patients

Sex

Female

Ages

30 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

375 participants in 1 patient group

TOBI + DBT
Experimental group
Description:
TOBI + DBT of women presenting for breast imaging.
Treatment:
Device: TOBI + DBT

Trial contacts and locations

1

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Central trial contact

Mansi Saksena, MBBS; Stefan Carp, PhD

Data sourced from clinicaltrials.gov

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