Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)

NCT ID: NCT02033486

Last Updated: 2019-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2021-03-31

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TOBI + DBT

TOBI + DBT of women presenting for breast imaging.

Group Type EXPERIMENTAL

TOBI + DBT

Intervention Type DEVICE

Interventions

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TOBI + DBT

Intervention Type DEVICE

Other Intervention Names

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Diffuse Optical Tomography + digital breast tomosynthesis

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mansi A Saksena

Assistant Professor at Massachusetts General Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan A Carp, PhD

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Mansi Saksena, MBBS

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Stefan Carp

Charlestown, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Stefan Carp, PhD

Role: CONTACT

617-643-2230

Mansi Saksena, MBBS

Role: CONTACT

617-726-3093

Facility Contacts

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Stefan Carp, PhD

Role: primary

617-643-2230

Mansi Saksena, MBBS

Role: backup

617-726-3093

Other Identifiers

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5R01CA142575

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01CA187595

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2013P000488

Identifier Type: -

Identifier Source: org_study_id

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