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Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Boas, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02033486
First received: January 9, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Breast Cancer
Device: TOBI + DBT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 375
Study Start Date: January 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TOBI + DBT
TOBI + DBT of women presenting for breast imaging.
Device: TOBI + DBT
Other Name: Diffuse Optical Tomography + digital breast tomosynthesis

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any adult female volunteers of any race or ethnic background, between the ages of 40 to 75, scheduled for a clinically indicated diagnostic mammogram or percutaneous biopsy.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02033486

Contacts
Contact: David Boas, PhD 617-724-0130 dboas@nmr.mgh.harvard.edu
Contact: Mansi Saksena, MBBS 617-726-3093 msaksena@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: David A Boas, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Study Director: David A Boas, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: David Boas, PhD, Professor of Radiology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02033486     History of Changes
Other Study ID Numbers: 2013P000488, 5R01CA142575
Study First Received: January 9, 2014
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
diffuse optical tomography
digital breast tomosynthesis
breast cancer
solid benign lesions
cysts
malignant lesions

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 27, 2014