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

NCT05975736 | Active Not Recruiting

• 1 other identifier: 2007P000646-E
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Mammography; Breast Cancer; Radiology

Outcome Measures

Primary Outcomes (2)

• Time required to respond to a case

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

  Through study completion, an average of 1 year

• 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.

  through study completion, an average of 1 year

Study Arms (2)

Blocked Trials

EXPERIMENTAL

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

Behavioral: Search only for masses; Behavioral: Search only for calcifications; Behavioral: Search for both together; Behavioral: Search for one after the other

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).

Behavioral: Search only for masses; Behavioral: Search only for calcifications; Behavioral: Search for both together; Behavioral: Search for one after the other

Interventions

Search only for masses BEHAVIORAL

Participants search the simulated mammogram for simulated masses.

Blocked Trials; Mixed Trials

Search only for calcifications BEHAVIORAL

Participants search the simulated mammogram for simulated calcifications.

Blocked Trials; Mixed Trials

Search for both together BEHAVIORAL

Search the simulated mammogram for both simulated masses and simulated calcifications at the same time.

Blocked Trials; Mixed Trials

Search for one after the other BEHAVIORAL

Search the simulated mammogram for first for simulated masses and then for simulated calcifications sequentially (or vice versa).

Blocked Trials; Mixed Trials

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 yrs
• Pass Ishihara color vision test

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Calcification, Physiologic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biomineralization; Growth and Development; Physiological Phenomena; Bone Development; Musculoskeletal Development; Organogenesis; Embryonic and Fetal Development; Morphogenesis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jeremy M Wolfe, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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".
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: One group of observers will get separate blocks of each of four conditions. The other group will see all conditions, intermixed.

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: September 1, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: As soon as data collection and analysis is complete. Data will be available "forever"
• Access Criteria: Open

Locations

US (1)