Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TOBI + DBT
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring diffuse optical tomography, digital breast tomosynthesis, breast cancer, solid benign lesions, cysts, malignant lesions
Eligibility Criteria
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
Sites / Locations
- Stefan CarpRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TOBI + DBT
Arm Description
TOBI + DBT of women presenting for breast imaging.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02033486
First Posted
January 9, 2014
Last Updated
April 16, 2019
Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02033486
Brief Title
Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)
Official Title
Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
diffuse optical tomography, digital breast tomosynthesis, breast cancer, solid benign lesions, cysts, malignant lesions
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
375 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TOBI + DBT
Arm Type
Experimental
Arm Description
TOBI + DBT of women presenting for breast imaging.
Intervention Type
Device
Intervention Name(s)
TOBI + DBT
Other Intervention Name(s)
Diffuse Optical Tomography + digital breast tomosynthesis
Primary Outcome Measure Information:
Title
Area under the curve for distinguishing benign vs malignant lesions
Description
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.
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Carp, PhD
Phone
617-643-2230
Email
stefan.carp@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mansi Saksena, MBBS
Phone
617-726-3093
Email
msaksena@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan A Carp, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mansi Saksena, MBBS
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stefan Carp
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Carp, PhD
Phone
617-643-2230
Email
stefan.carp@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Mansi Saksena, MBBS
Phone
617-726-3093
Email
MSAKSENA@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Mansi Saksena, MBBS
First Name & Middle Initial & Last Name & Degree
Stefan Carp, PhD
12. IPD Sharing Statement
Learn more about this trial
Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)
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