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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)|
- Area under the curve for distinguishing benign vs malignant lesions [ Time Frame: 5 years ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||January 2019|
|Estimated Primary Completion Date:||January 2019 (Final data collection date for primary outcome measure)|
Experimental: TOBI + DBT
TOBI + DBT of women presenting for breast imaging.
Device: TOBI + DBT
Other Name: Diffuse Optical Tomography + digital breast tomosynthesis
Please refer to this study by its ClinicalTrials.gov identifier: NCT02033486
|Contact: David Boas, PhDemail@example.com|
|Contact: Mansi Saksena, MBBSfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator: David A Boas, PhD|
|Study Director:||David A Boas, PhD||Massachusetts General Hospital|