Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03842358
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : December 8, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Ultrasound-guided diffuse optical tomography (DOT) has demonstrated its potential role in differentiating malignant and benign breast abnormalities and in predicting and monitoring the neoadjuvant chemotherapy (NAC) response of breast cancer. This unique approach employs a commercial ultrasound (US) transducer and near infrared (NIR) optical imaging sensors mounted on a hand-held US probe. The co-registered US is used for lesion localization, and optical sensors are used for imaging tumor related vascularity.

Condition or disease Intervention/treatment Phase
Breast Biopsy Device: Hand-held hybrid probe Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 335 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Improving Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Phase I - Training Set
  • 20 patients will be recruited to undergo US-DOT and CEM to allow for training study readers in assessing US-DOT data, intra-observer variability and to assess inter-observer variability in the assessment of US-DOT data
  • A hand-held hybrid probe will be used for the scans
 Device: Hand-held hybrid probe
Consists of a commercially available US transducer located in the middle and near-infrared source and detector optical fibers distributed at the periphery
Experimental: Phase 2: Prospective Trial
  • US-DOT (US/NIR) Imaging Exam
  • Breast biopsy or FNA performed (standard of care)
  • A hand-held hybrid probe will be used for the scans
 Device: Hand-held hybrid probe
Consists of a commercially available US transducer located in the middle and near-infrared source and detector optical fibers distributed at the periphery


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Impact of US-guided DOT on the potential reduction of benign biopsies as measured by comparing the specificity of conventional imaging (CI = US +/- Mammography) alone versus CI & US-DOT [ Time Frame: Completion of enrollment for all patients (estimated to be 75 months) ]
    -BI-RADS scores without and then with optical data will be rendered by study radiologists. Radiologists will be blinded to the biopsy exam and pathology outcomes. Optical data including total Hemoglobin concentration will be provided by the bioengineering team. Specificity will be calculated as the proportion of subjects with a non- suspicious assessment, i.e. BIRADS 2 'benign' or BIRADS 3 'probably benign', divided by the denominator of subjects with no cancer demonstrated at biopsy. US-guided core biopsy results and subsequent surgical pathology (if present) will be entered by the study pathologist.

  2. Impact of US-guided DOT as an adjunct to conventional breast imaging on maintaining high sensitivity as measured by comparing the false negative rate of conventional imaging (CI=US +/- Mammography) alone versus CI & US-DOT [ Time Frame: Completion of enrollment for all patients (estimated to be 75 months) ]
    -BI-RADS scores without and then with optical data will be rendered by study radiologists. Radiologists will be blinded to the biopsy exam and pathology outcomes. Optical data including total Hemoglobin concentration will be provided by the bioengineering team. The False Negative Rate will be calculated as the proportion of subjects with a non-suspicious assessment i.e. BIRADS 2 'benign' or BIRADS 3 'probably benign', who have cancer (defined as Invasive cancer or Ductal Carcinoma In Situ) demonstrated at biopsy divided by the denominator of all subjects with cancer. US-guided core biopsy results and subsequent surgical pathology (if present) will be entered by the study pathologist


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female subjects ≥ 18 years old with ultrasound visible breast abnormalities (BI-RADS 3*, 4A, 4B, 4C, and 5) referred for ultrasound-guided core needle biopsy or fine needle aspiration

    *note that while a BI-RADS 3 assessment is probably benign, a subset of patients with this assessment choose to undergo biopsy rather than follow up imaging).

  • Willing and able to provide informed consent

Exclusion Criteria:

  • Lesions located in the darkly pigmented nipple-areolar complex area
  • Subjects with breast implants
  • Abnormality in the mirror image location of the contralateral breast.
  • Additional abnormalities in the same region of the breast that would be included in US-guided DOT imaging of the abnormality undergoing biopsy
  • Previous breast irradiation of the mirror image location of the contralateral breast
  • Lesions located at previous biopsy sites when biopsy occurred within the last six months.
  • Small lesions of less than 1 cm located at skin or close to the skin
  • Pregnancy
  • Superficial abnormalities located entirely within (i.e. less than) 5mm of the overlying skin
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03842358


Contacts
Layout table for location contacts
Contact: Debbie Bennett, M.D. 314-454-7696 debbie.bennett@wustl.edu

Locations
Layout table for location information
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Cheryl Herman, M.D.    314-454-7696    hermanc@wustl.edu   
Principal Investigator: Debbie Bennett, M.D.         
Sub-Investigator: Ian Hageman, M.D., Ph.D.         
Sub-Investigator: Quing Zhu, Ph.D.         
Sub-Investigator: JingQin Luo         
Sub-Investigator: Kimberly Wiele, M.D.         
Sub-Investigator: Steven Poplack, M.D.         
Sub-Investigator: Jamiee Mannix, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Debbie Bennett, M.D. Washington University School of Medicine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03842358    
Other Study ID Numbers: 201707042
1R01CA228047-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: December 8, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No