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New breast CT scan could cut unnecessary Call-Backs

NCT ID NCT05036096

Diagnosis Sponsor: Koning Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a new cone beam breast CT scan to standard digital mammography for breast cancer screening. About 1,024 women aged 30 or older (40+ for screening) will get both scans within 4 weeks. Researchers want to see if the new scan gives a similar or lower radiation dose and reduces the number of women called back for extra tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cone beam breast CT imaging device
What this could lead to
If successful, this could offer a more comfortable and accurate breast cancer screening method that reduces unnecessary call-backs.
What could go wrong
This is a mid-sized study comparing a new device to standard mammography. The new scan may not detect cancers as well or could have higher radiation in practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,024 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Screening Group: * Female sex of any ethnicity * Age 40 years or older * Scheduled for a routine screening mammography exam within 4 weeks. Diagnostic Group: * Female sex of any ethnicity * Age 30 years or older * Have an abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE), or have an abnormality detected by an imaging modality. * Will undergo diagnostic mammography, prior to breast biopsy (if needed). Exclusion Criteria: * Pregnancy * Lactation * Unknown pregnancy status AND * has refused pregnancy testing and * has refused to sign a pregnancy test waiver * Women who are unable or unwilling to understand or to provide informed consent * Women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker. * Women who are unable to tolerate study constraints. * Women who have received radiation treatments to the thorax or breast area for malignant and nonmalignant conditions, such as (but not limited to): * Treatment for enlarged thymus gland as an infant * Irradiation for benign breast conditions, including breast inflammation after giving birth * Treatment for Hodgkin's disease * Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram. * Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to): * Tuberculosis * Severe scoliosis Additional exclusion criteria due to machine limitations * Patient's body weight is over the limit of the scanner table (440 lbs. or 200kg)

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Knoxville Comprehensive Breast Center

    Knoxville, Tennessee, 37909, United States

  • Port Orange Imaging Center

    Port Orange, Florida, 32129, United States

  • The Howard Center for Women's Health

    Tifton, Georgia, 31794, United States

  • Women's Imaging Specialists

    Dacula, Georgia, 30019, United States

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