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NCT05960188 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Brigham and Women's Hospital.

Completed
Registry status
NA
Development phase
16
Enrollment target

NCT05960188 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 16 participants.

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The verdict

NCT05960188, a NA study, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
NA
Development phase
16 participants
Enrollment target

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.

Interventions

  • BEHAVIORAL AI Opinion

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2023-03-01
Est. Completion 2023-03-04
Phase NA

Sponsor

Brigham and Women's Hospital

937 total trials

What the Registry Record Tells You About NCT05960188

The ClinicalTrials.gov registry entry for NCT05960188 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which AI Opinion is the first listed.

NCT05960188 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05960188 about?

NCT05960188 is a clinical study titled "Project 1: Self-Triage by 2D Full-field Digital Mammography or Synthetic Images". 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 a...

What is the current status of trial NCT05960188?

This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2023-03-01. Estimated completion is 2023-03-04.

What interventions are being tested in trial NCT05960188?

The interventions under investigation include: AI Opinion (BEHAVIORAL).

Who is sponsoring clinical trial NCT05960188?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.