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Artificial Intelligence

Review with assistance of S-Detect for Breast for Breast Cancer

N/A
Waitlist Available
Led By Avice O'Connell
Research Sponsored by Samsung Medison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult females or males recommended for ultrasound-guided breast lesion biopsy or ultrasound follow-up with at least one suspicious lesion
Age > 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 day
Awards & highlights

Study Summary

This study evaluates a second review of ultrasound images of breast lesions using an interactive "deep learning" (or artificial intelligence) program developed by Samsung Medical Imaging, to see if this artificial intelligence will help the Radiologist make more accurate diagnoses.

Eligible Conditions
  • Breast Cancer
  • Breast Lesions
  • Breast Lump

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Concordance rate
Secondary outcome measures
Accuracy
Area Under Curve
Consensus
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Review with assistance of S-Detect for BreastExperimental Treatment3 Interventions
Second, the images will be reviewed by the radiologists with the help of artificial intelligence system, which is an interactive tool automatically providing recommendations on BIRADS descriptor choices that can be modified by the radiologists. The radiologists, after selecting all the descriptors of BIRADS, will decide the assessment categories. These decisions will be compared with the ground truths generated from the biopsy results or a 24-month follow-up (CADx).
Group II: Review by S-Detect for BreastExperimental Treatment2 Interventions
The same images will be separately processed by the artificial intelligence system (S-Detect for Breast) by Samsung. The two results, one by the radiologists and the other by artificial intelligence system, will be compared to statistically quantify equivalence (CADe).
Group III: Manual reviewActive Control4 Interventions
The images will be reviewed by the radiologists using BIRADS scheme without any assistance of artificial assistance. This review will be done off-line using a separate program in entirely manual mode. During this review, BIRADS descriptor choices by each radiologist and the time it takes for the radiologist to make such decision will be stored. Radiologists also make assessment decision without any intervention from artificial intelligence. 10 radiologists review manually.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~840

Find a Location

Who is running the clinical trial?

Samsung MedisonLead Sponsor
5 Previous Clinical Trials
1,223 Total Patients Enrolled
University of RochesterOTHER
835 Previous Clinical Trials
518,026 Total Patients Enrolled
11 Trials studying Breast Cancer
1,413 Patients Enrolled for Breast Cancer
Avice O'ConnellPrincipal InvestigatorDepartment of Imaging Sciences, University of Rochester

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Breast Ultrasound Image Reviewed With Assistance of Deep Learning Algorithms
2018. "Breast Ultrasound Image Reviewed With Assistance of Deep Learning Algorithms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03706534.
~46 spots leftby Apr 2025
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