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临床试验/NCT05975736
NCT05975736进行中(未招募)不适用

Improving Perception in Digital Breast Tomography: Searching for Masses and Calcifications at the Same Time. NOTE: Note, This is One Study Under Study ID 386409 Projects 1,2,3: Experiments With Non Experts

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
70
试验地点
2
主要终点
Time required to respond to a case

研究概览

简要总结

Brief Summary

A task like breast cancer screening (mammography) can be described as a "hybrid search" task. In basic visual search tasks, observers search for a target among distractors that are not the target. In hybrid search, observers search for two or more target types. In mammography, observers are searching for masses, calcifications ("calcs"), and some other signs of cancer like architectural distortion. In this experiment, the investigators have created a simulated version of mammography where non-expert (non-radiologist) observers can look for simulated masses and calcs. There are two types of stimuli, a 2D version (like an x-ray) and a 3D version (like the output of Digital Breast Tomosynthesis - DBT). The question that is being asked is whether it is better to ask about masses and calcs separately (first one, then the other) or to just let observers look for both at the same time.

详细描述

Brief Summary

A task like breast cancer screening (mammography) can be described as a "hybrid search" task. In basic visual search tasks, observers search for a target among distractors that are not the target. In hybrid search, observers search for two or more target types. In mammography, observers are searching for masses, calcifications ("calcs"), and some other signs of cancer like architectural distortion. In this experiment, the investigators have created a simulated version of mammography where non-expert (non-radiologist) observers can look for simulated masses and calcs. There are two types of stimuli, a 2D version (like an x-ray) and a 3D version (like the output of Digital Breast Tomosynthesis - DBT). The question that is being asked is whether it is better to ask about masses and calcs separately (first one, then the other) or to just let observers look for both at the same time.

Extended protocol

NOTE: This registration is linked to a Human Subjects registration in ASSIST. That, in turn, is part of an NCI Grant, CA207490. The grant describes many proposed experiments and notes that many others might be done as follow-up studies. At the suggestion of the NIH, the investigators grouped these studies into three "studies", each covering multiple experiments. The experiment described here is part of "Study ID 386409 Projects 1,2,3: Experiments with Non experts". It is not possible to register a set of experiments through the PRS system in CT.gov and it is not possible to file an annual report for the grant (RPPR) without an NCT number for projects that have started collecting participants. Accordingly, the investigators are describing one experiment here that would be part of the "Project 2" bundle of studies.

These experiments take what is known about "hybrid search" tasks from the lab and applies it to clinical mammography. Hybrid search tasks are tasks that involve looking for more than one type of target at the same time (e.g. search for this pillow and any animal in the scene in front of you).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

盲法说明

Participants will not know the goals of the study but they will be fully informed about the conditions and asked to respond "as quickly and accurately as possible".

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age over 18 yrs
  • Pass Ishihara color vision test

排除标准

  • vision less than 20/25 with correction
  • history of neuromuscular or visual disorders

研究组 & 干预措施

Blocked Trials

Experimental

There are four conditions in the experiment. Each condition will be presented in a separate block of 100 trials.

干预措施: Search only for calcifications (Behavioral)

Blocked Trials

Experimental

There are four conditions in the experiment. Each condition will be presented in a separate block of 100 trials.

干预措施: Search for both together (Behavioral)

Blocked Trials

Experimental

There are four conditions in the experiment. Each condition will be presented in a separate block of 100 trials.

干预措施: Search for one after the other (Behavioral)

Mixed Trials

Experimental

There are four conditions in the experiment. All condition will be presented, randomly mixed in a single block of 400 trials (with breaks every 100 trials).

干预措施: Search only for masses (Behavioral)

Mixed Trials

Experimental

There are four conditions in the experiment. All condition will be presented, randomly mixed in a single block of 400 trials (with breaks every 100 trials).

干预措施: Search only for calcifications (Behavioral)

Mixed Trials

Experimental

There are four conditions in the experiment. All condition will be presented, randomly mixed in a single block of 400 trials (with breaks every 100 trials).

干预措施: Search for both together (Behavioral)

Mixed Trials

Experimental

There are four conditions in the experiment. All condition will be presented, randomly mixed in a single block of 400 trials (with breaks every 100 trials).

干预措施: Search for one after the other (Behavioral)

Blocked Trials

Experimental

There are four conditions in the experiment. Each condition will be presented in a separate block of 100 trials.

干预措施: Search only for masses (Behavioral)

结局指标

主要结局

Time required to respond to a case

时间窗: Through study completion, an average of 1 year

The measure of response time is an index of the difficulty of each case.

Rates of false positive and false negative errors

时间窗: through study completion, an average of 1 year

Cases are either positive or negative for simulated cancer. Responses are either correct or incorrect in identifying if the case is positive or negative. Hence each response is either a true or false positive and or a true or false negative response. The relative percentages of these errors provides a measure of accuracy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeremy M Wolfe, PhD

Professor

Brigham and Women's Hospital

研究点 (2)

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