18 and older, female only, with Breast Biopsy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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-DOTPrimary· 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 pre
Group
Value
95% CI
US-DOT (US/NIR) Imaging
148
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-DOTPrimary· 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 divid
Group
Value
95% CI
US-DOT (US/NIR) Imaging
5
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 26 September 2025
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