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Completed

NCT Number: NCT03842358

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

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.

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Key information

Conditions

Breast Biopsy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Pregnancy
  • Superficial abnormalities located entirely within (i.e. less than) 5mm of the overlying skin

Treatment and study plan

Hand-held hybrid probe

Device

Consists of a commercially available US transducer located in the middle and near-infrared source and detector optical fibers distributed at the periphery

Primary outcomes

  1. Impact of US-guided DOT on the Potential Reduction of Benign Biopsies as Measured by Comparing the Reads With a Non- Suspicious Assessment of Conventional Imaging (CI) Alone Versus CI & US-DOT

    Time frame: Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient

    -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. Benign biopsy reduction will be calculated as the proportion of reads (CI & US-DOT subtract CI) with a non- suspicious assessment, i.e. BIRADS 2 'benign' or BIRADS 3 'probably benign', divided by the denominator of total reads 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 or Missing Malignancy of Conventional Imaging (CI=US +/- Mammography) Alone Versus CI & US-DOT

    Time frame: Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient

    -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 engineering team is also blinded to the biopsy exam and pathology outcomes. The False Negative Rate will be calculated as the proportion of reads 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 reads with cancer. US-guided core biopsy results and subsequent surgical pathology (if present) will be entered by the study pathologist.

  3. Assess the Impact of Adjunctive US-guided DOT Data in the Management of Discordant Pathology Results

    Time frame: Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Feb 15, 2019
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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