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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA142575 | U.S. NIH Grant/Contract | View source | |
| R01CA187595 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOBI + DBT | Experimental | TOBI + DBT of women presenting for breast imaging. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOBI + DBT | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Any adult female volunteers of any race or ethnic background, between the ages of 30 to 80, either
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Carp, PhD | Contact | 617-643-2230 | stefan.carp@mgh.harvard.edu | |
| Mansi Saksena, MBBS | Contact | 617-726-3093 | msaksena@partners.org |
| Name | Affiliation | Role |
|---|---|---|
| Stefan A Carp, PhD | Massachusetts General Hospital | Study Director |
| Mansi Saksena, MBBS | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stefan Carp | Recruiting | Charlestown | Massachusetts | 02129 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003560 | Cysts |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008327 | Mammography |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |