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Searching for Masses and Calcifications at the Same Time in Breast Cancer Screening

Primary Purpose

Mammography, Breast Cancer, Radiology

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Search only for masses
Search only for calcifications
Search for both together
Search for one after the other
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mammography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age over 18 yrs Pass Ishihara color vision test Exclusion Criteria: vision less than 20/25 with correction history of neuromuscular or visual disorders

Sites / Locations

  • Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Blocked Trials

Mixed Trials

Arm Description

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

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).

Outcomes

Primary Outcome Measures

Time required to respond to a case
The measure of response time is an index of the difficulty of each case.
Rates of false positive and false negative errors
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.

Secondary Outcome Measures

Full Information

First Posted
July 27, 2023
Last Updated
August 2, 2023
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05975736
Brief Title
Searching for Masses and Calcifications at the Same Time in Breast Cancer Screening
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 1, 2027 (Anticipated)
Study Completion Date
September 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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). Standard 2D mammography and 3D DBT can be thought of as hybrid search tasks. That is, mammography can be thought of as a hybrid search for masses and calcifications. What is the optimal way to do this task? Should readers look for both types of targets at the same time or should they be asked to look for one target type and then the other. It is likely that the sequential approach improves accuracy but at some cost in time. The investigators will test that hypothesis of a "speed/accuracy tradeoff". The investigators have developed a version of the 2D mammography task that can be run on non-experts. Breast parenchyma is simulated with 1/fk noise (k=1.8 - 2.8). Artificial masses and calcifications (calcs) can be added to this background. Masses are relatively low contrast blobs that are deemed to be "bad" if they have many irregular bumps and benign if they are smoother. Calcs are brighter, higher contrast, small spots. These are deemed to be benign unless they form a cluster of nearby spots in the image. The task is designed to be hard. The goal is performance producing a d' value in the range of 2.0 to 2.5. Bad and benign stimuli are selected from uniformly distributed stimuli sets. For masses, when the target is 'bad', bad mass is randomly selected from 5 levels of bumpiness. The same rule is applied for selecting benign stimuli from five less-bumpy levels. For calcifications, the number of pixels in a cluster is randomly selected between 4~12. There are four conditions to be tested in the first experiment: Search for masses alone Search for calcs alone Search for both together Search for one after the other (mass -> calc) or (calc -> mass) In addition, there are two different ways of presenting the four conditions. These could be considered to be two arms of the study. Either participants could see each condition in a block of 100 trials or the four conditions could be mixed into one set of 400 trials (with breaks every 100 trials to keep the pacing of the experiment consistent. In the initial experiment, target prevalence will be 60%. In future experiments, lower prevalence will be tested. The measures of interest are accuracy and RT and the most interesting question is whether the sequential condition produces any benefits that might be worth the presumed cost in time. The 3D version is like the 2D version except that a volume of 1/fk noise is created and masses and calcs are added so that they fade in and out of view as the observer scrolls through "slices" through the 3D volume. This simulates DBT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mammography, Breast Cancer, Radiology

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group of observers will get separate blocks of each of four conditions. The other group will see all conditions, intermixed.
Masking
None (Open Label)
Masking Description
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".
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blocked Trials
Arm Type
Experimental
Arm Description
There are four conditions in the experiment. Each condition will be presented in a separate block of 100 trials.
Arm Title
Mixed Trials
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Search only for masses
Intervention Description
Participants search the simulated mammogram for simulated masses.
Intervention Type
Behavioral
Intervention Name(s)
Search only for calcifications
Intervention Description
Participants search the simulated mammogram for simulated calcifications.
Intervention Type
Behavioral
Intervention Name(s)
Search for both together
Intervention Description
Search the simulated mammogram for both simulated masses and simulated calcifications at the same time.
Intervention Type
Behavioral
Intervention Name(s)
Search for one after the other
Intervention Description
Search the simulated mammogram for first for simulated masses and then for simulated calcifications sequentially (or vice versa).
Primary Outcome Measure Information:
Title
Time required to respond to a case
Description
The measure of response time is an index of the difficulty of each case.
Time Frame
Through study completion, an average of 1 year
Title
Rates of false positive and false negative errors
Description
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.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age over 18 yrs Pass Ishihara color vision test Exclusion Criteria: vision less than 20/25 with correction history of neuromuscular or visual disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy M Wolfe, PhD
Phone
617-851-1166
Email
jwolfe@bwh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ava A Mitra, BA
Phone
617-525-3681
Email
amitra@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy M Wolfe, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ava A Mitra, BA
Phone
617-525-3681
Email
amitra@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Jeremy M Wolfe, PhD
Phone
617-851-1166
Email
jwolfe@bwh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data are posted on the Open Science Framework
IPD Sharing Time Frame
As soon as data collection and analysis is complete. Data will be available "forever"
IPD Sharing Access Criteria
Open

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Searching for Masses and Calcifications at the Same Time in Breast Cancer Screening

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