Recruiting

TOBI

Sponsor:

Massachusetts General Hospital

Code:

NCT02033486

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 30 - 70+

Healthy Volunteers: Accepted

Interventions

TOBI + DBT

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT02033486

Start date

Mar, 2014

Status verified date

Apr, 2019

Completion date

Mar, 2021

Anticipated

Primary completion date

Mar, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30 - 70+

Healthy Volunteers: Accepted

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

Enrollment

375 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: TOBI + DBT

TOBI + DBT of women presenting for breast imaging.

Interventions

TOBI + DBT

Primary outcome measure

  • Area under the curve for distinguishing benign vs malignant lesions [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

Stefan Carp

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

Principal Investigator:

Mansi Saksena, MBBS

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 18, 2019

Last verified

Apr, 2019

Keywords

  • diffuse optical tomography
  • digital breast tomosynthesis
  • breast cancer
  • solid benign lesions
  • cysts
  • malignant lesions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2019-04-18.