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MammographyNCT05975736

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

A study testing Search only for masses, Search only for calcifications and Search for both together in people with Mammography and Breast Cancer, run by Brigham and Women's Hospital at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mammography, Breast Cancer, Radiology
What is being tested?
Search only for masses, Search only for calcifications and Search for both together
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
1 Sep 2022to 1 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age over 18 yrs
  • Pass Ishihara color vision test

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215

Other trials in United States

About this study

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

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.

Read the 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:

  1. Search for masses alone
  2. Search for calcs alone
  3. Search for both together
  4. 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.

Being tested
Search only for masses, Search only for calcifications, Search for both together, Search for one after the other
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Search only for massesBehavioural

    Participants search the simulated mammogram for simulated masses.

  • Search only for calcificationsBehavioural

    Participants search the simulated mammogram for simulated calcifications.

  • Search for both togetherBehavioural

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

  • Search for one after the otherBehavioural

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

Study groups in NCT05975736
Study groupRoleWhat they receive
Blocked TrialsExperimentalThere are four conditions in the experiment. Each condition will be presented in a separate block of 100 trials.
Receives: Behavioral: Search only for masses; Behavioral: Search only for calcifications; Behavioral: Search for both together; Behavioral: Search for one after the other
Mixed TrialsExperimentalThere 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).
Receives: Behavioral: Search only for masses; Behavioral: Search only for calcifications; Behavioral: Search for both together; Behavioral: Search for one after the other

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time required to respond to a case

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

    Measured: Through study completion, an average of 1 year

  2. 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.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2023
  2. Study start1 Sep 2022
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05975736
Sponsor's protocol ID
2007P000646-E
Status last verified
Aug 2026
First submitted
27 Jul 2023
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data are posted on the Open Science Framework

Questions about this trial

What is this clinical trial studying?

A study testing Search only for masses, Search only for calcifications and Search for both together in people with Mammography and Breast Cancer, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time required to respond to a case (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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