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

Not Applicable

Recruiting

• Conditions: Breast Biopsy
• Interventions: Device: Hand-held hybrid probe

• Registration Number: NCT03842358
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-13
• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 335

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 2: Prospective Trial	Hand-held hybrid probe	* 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
Phase I - Training Set	Hand-held hybrid probe	* 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

Primary Outcome Measures

Name	Time	Method
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	Completion of enrollment for all patients (estimated to be 87 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
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	Completion of enrollment for all patients (estimated to be 87 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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States