Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)

NCT02033486 | Unknown

• 3 other identifiers: 2013P0004885R01CA142575R01CA187595
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Area under the curve for distinguishing benign vs malignant lesions

  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.

  5 years

Study Arms (1)

TOBI + DBT

EXPERIMENTAL

TOBI + DBT of women presenting for breast imaging.

Device: TOBI + DBT

Interventions

TOBI + DBT DEVICE

Also known as: Diffuse Optical Tomography + digital breast tomosynthesis

TOBI + DBT

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stefan Carp

Charlestown, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Cysts

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Stefan A Carp, PhD

  Massachusetts General Hospital

  STUDY DIRECTOR

• Mansi Saksena, MBBS

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Carp, PhD

CONTACT

617-643-2230; stefan.carp@mgh.harvard.edu

Mansi Saksena, MBBS

CONTACT

617-726-3093; msaksena@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor at Massachusetts General Hospital

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 10, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)