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New imaging combo could spot hidden breast cancers in dense tissue

NCT ID NCT03220893

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at over 3,000 women with dense breast tissue to see if adding molecular breast imaging (MBI) to standard digital breast tomosynthesis (DBT) finds more invasive cancers. MBI uses a small amount of radioactive material to highlight active cells, like cancer. The goal is to improve early detection in women whose dense tissue can hide tumors on regular mammograms.

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

3,023 people

The number who actually took part.

Started

Jun 2017

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

40 to 75 years

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: * Patient is a consenting female age 40-75 years * Patient is scheduled for routine screening DBT * Patient is asymptomatic for breast disease * Patient had heterogeneously dense or extremely dense breasts on most recent prior mammography examination (Breast Imaging Reporting and Data System \[BI-RADS\] c or d) within 24 months of enrollment * Patient is able to participate fully in all aspects of the study (completing study visits and study data collection) * Patient understands and signs the study informed consent * Patient anticipates being able to return one year after study enrollment to complete the second round of screening Exclusion Criteria: * Patient is currently pregnant or plans to become pregnant during the course of the study * Patient is currently lactating * Patient has had a prior MBI * Patient has had a prior whole breast ultrasound (WBUS) for screening, with either a hand-held ultrasound probe or automated system, within 12 months prior to study enrollment * Patient has had a prior breast MRI * Patient has had a prior contrast-enhanced mammogram (contrast enhanced spectral mammography \[CESM\] or contrast-enhanced digital mammography \[CEDM\]) * Patient is concurrently participating in any other breast imaging research studies that involve undergoing additional breast imaging tests beyond routine screening with mammography, including but not limited to contrast-enhanced mammography, WBUS, MBI, or contrast-enhanced breast MRI * Patient has had a breast biopsy within 3 months prior to study enrollment * Patient has had breast surgery within 12 months prior to study enrollment * Patient is currently undergoing treatment for breast cancer or planning surgery for a high-risk breast lesion (atypical ductal hyperplasia \[ADH\], atypical lobular hyperplasia \[ALH\], lobular carcinoma in situ \[LCIS\], papilloma, radial scar) * Patient is currently taking a chemoprevention agent for breast cancer risk reduction or osteoporosis prevention (tamoxifen, raloxifene, anastrazole, letrozole, exemestane) * Patient has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mayo Clinic Health System-Franciscan Healthcare

    La Crosse, Wisconsin, 54601, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • Toledo Clinic Cancer Centers-Toledo

    Toledo, Ohio, 43623, United States

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