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

Breast Biopsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03842358
• Other study ID #: 201707042
• Secondary ID: 1R01CA228047-01A
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2018
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: Debbie Bennett, M.D.
• Phone: 314-454-7696
• Email: debbie.bennett[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 335
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Biopsy

Intervention

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	-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.	Completion of enrollment for all patients (estimated to be 87 months)
Primary	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	-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	Completion of enrollment for all patients (estimated to be 87 months)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine