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Project 1: Self-Triage by 2D Full-field Digital Mammography or Synthetic Images

NCT05960188 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-12-11

No results posted yet for this study

Summary

One method of breast cancer screening involves radiologists reading digital tomosynthesis (DBT) images. DBT consists of a 3D stack of x-ray "slices" through the breast. The exam is accompanied by a 2D image like a standard mammogram, a single x-ray of the breast. In a screening setting, most cases are normal. Sometimes it is obvious that a case is normal from a quick look at the 2D image. It would speed up the process of screening if readers could dismiss a clearly normal case on the basis of the 2D image, alone, without looking at the DBT images. Obviously, the investigators would only want to "triage" cases in this way if the investigators were almost perfectly sure that no cancers would be missed. In this study, the investigators look at radiologist's willingness to triage cases and on the accuracy of their answers. In addition, the investigators ask about the impact of an Artificial Intelligence (AI) opinion. Would it be possible to triage an image on the basis of the AI opinion, alone?

Radiologists will look at each case for up to five seconds and offer an opinion (on a 1-10 scale) about how sure they are that a case is normal. Next, they will see the opinion of the AI. Finally, they will say (using a 1-10) scale, how willing they would be for the AI to triage this case without human intervention.

This study is the start of an effort to understand the conditions under which radiologists might be willing to declare a case "normal" with little or no human examination.

Conditions

  • Breast Cancer Screening

Interventions

BEHAVIORAL

AI Opinion

For each case, we give the radiologist a numeric score reflecting the AI's rating of the abnormality of the case.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-03-04
Completion
2023-03-04

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05960188 on ClinicalTrials.gov