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Studies

Interventional Active not recruiting

NCT05975736 on ClinicalTrials.gov

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

  • Sponsor: Brigham and Women's Hospital
  • Enrollment: 70 (Estimated)
  • Study start: 2022-09-01 (Actual)
  • Primary completion: 2027-09-01 (Estimated)
  • Study completion: 2028-09-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: One group of observers will get separate blocks of each of four conditions. The other group will see all conditions, intermixed.
  • Masking: None
  • PrimaryPurpose: Basic Science

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

Intervention / Treatment

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

Primary Outcome Measures

  • Time required to respond to a case (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 (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.

Countries

United States

Locations and Investigators

  • Brigham and Women's Hospital, Boston, United States

Study Officials