Trial Outcomes & Findings for Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography (NCT NCT03842358)

NCT ID: NCT03842358

Last Updated: 2025-09-26

Results Overview

-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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 298 participants
• Primary outcome timeframe: Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient
• Results posted on: 2025-09-26

Participant Flow

The protocol states that there are two phases: phase I - training set and phase 2 - prospective trial. For the training set, the readers underwent an approximately 60-minute training session using a tool created from a pre-existing representative DOT findings in patients who had previously undergone US-guided DOT and who had a spectrum of documented benign and malignant pathology. Those patients were not consented or enrolled in this study and are not included in the presented data.

Participant milestones

Measure	US-DOT (US/NIR) Imaging * 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
Overall Study STARTED	298
Overall Study COMPLETED	286
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Measure	US-DOT (US/NIR) Imaging * 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
Overall Study Poor DOT probe contact with breast	2
Overall Study DOT system problem	1
Overall Study Switched to x-ray guided biopsy	3
Overall Study No biopsy after physician review	4
Overall Study Patient withdrew	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	US-DOT (US/NIR) Imaging n=298 Participants * 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
Age, Continuous	50 years n=5 Participants
Sex: Female, Male Female	298 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	287 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	86 Participants n=5 Participants
Race (NIH/OMB) White	201 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	298 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	US-DOT (US/NIR) Imaging n=628 BIRADS assessments * 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
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	148 BIRADS assessments

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	US-DOT (US/NIR) Imaging n=329 BIRADS assessments * 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
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	5 BIRADS assessments

PRIMARY outcome

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

Population: There were not any cases that were considered discordant in clinical practice as such there was not any data to present for this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

US-DOT (US/NIR) Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Debbie Bennett, M.D.

Washington University School of Medicine

Phone: 314-454-7696

Email: debbie.bennett@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place