Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)

Not Applicable

• Conditions: Breast Cancer
• Interventions: Device: TOBI + DBT

• Registration Number: NCT02033486
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-09
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-10
• Study Start: 2014-03
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 375

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TOBI + DBT	TOBI + DBT	TOBI + DBT of women presenting for breast imaging.

Primary Outcome Measures

Name	Time	Method
Area under the curve for distinguishing benign vs malignant lesions	5 years	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.

Trial Locations

Locations (1)

Stefan Carp; 🇺🇸 Charlestown, Massachusetts, United States