Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Massachusetts General Hospital
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Boas, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02033486
First received: January 9, 2014
Last updated: November 10, 2015
Last verified: November 2015

January 9, 2014
November 10, 2015
March 2014
January 2019   (final data collection date for primary outcome measure)
Area under the curve for distinguishing benign vs malignant lesions [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT02033486 on ClinicalTrials.gov Archive Site
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Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)
Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)
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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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
Device: TOBI + DBT
Other Name: Diffuse Optical Tomography + digital breast tomosynthesis
Experimental: TOBI + DBT
TOBI + DBT of women presenting for breast imaging.
Intervention: Device: TOBI + DBT
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
375
January 2019
January 2019   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any adult female volunteers of any race or ethnic background, between the ages of 40 to 75, either

    • scheduled for a clinically indicated diagnostic mammogram or percutaneous biopsy.
    • presenting for breast cancer treatment

Exclusion Criteria:

  • Under 40 years old or over 75 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
Female
40 Years to 75 Years   (Adult, Senior)
Yes
Contact: David Boas, PhD 617-724-0130 dboas@nmr.mgh.harvard.edu
Contact: Mansi Saksena, MBBS 617-726-3093 msaksena@partners.org
United States
 
NCT02033486
2013P000488, 5R01CA142575, R01CA187595
No
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David Boas, PhD, Massachusetts General Hospital
Massachusetts General Hospital
National Cancer Institute (NCI)
Study Director: David A Boas, PhD Massachusetts General Hospital
Massachusetts General Hospital
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP