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Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)

NCT02033486 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2019-04-18

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

TOBI + DBT

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Stefan A Carp, PhD · Massachusetts General Hospital

  • Mansi Saksena, MBBS · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02033486 on ClinicalTrials.gov