Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)
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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
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Volunteers
Inclusion criteria
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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
Allocation
Interventional model
Masking
375 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Mansi Saksena, MBBS; Stefan Carp, PhD
Data sourced from clinicaltrials.gov
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