30 Participants Needed

AI Triage for Breast Cancer Screening

JM
AA
Overseen ByAva A Mitra, BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for radiologists or radiology trainees with experience in reading mammography. Participants must have good vision, at least 20/25 with correction, to be eligible.

Inclusion Criteria

Radiologists or radiology trainees with some experience reading mammography

Exclusion Criteria

Acuity less than 20/25 with correction

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiologist Evaluation

Radiologists evaluate 2D mammogram images for up to 5 seconds and provide a normality rating. They also assess AI's opinion on the images.

1 year
Single session at conference or lab setting

AI Evaluation

AI system evaluates the same images and provides a probability of malignancy score. Radiologists assess the AI's ability to triage cases.

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Trial Overview The study tests if radiologists can quickly identify normal breast cancer screening cases using only a 2D image and whether an AI's opinion could help them decide without reviewing the full DBT images.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+
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