Print

Purpose

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

Eligibility

Eligible Ages
Between 30 Years and 80 Years
Eligible Genders
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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TOBI + DBT 		TOBI + DBT of women presenting for breast imaging.
  • Device: TOBI + DBT
    Other names:
    • Diffuse Optical Tomography + digital breast tomosynthesis

Recruiting Locations

Stefan Carp
Charlestown, Massachusetts 02129
Contact:
Stefan Carp, PhD
617-643-2230
stefan.carp@mgh.harvard.edu

More Details

Status
Unknown status
Sponsor
Massachusetts General Hospital

Study Contact

Stefan Carp, PhD
617-643-2230
stefan.carp@mgh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.