New imaging combo could spot hidden breast cancers in dense tissue
NCT ID NCT03220893
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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3,023 people
The number who actually took part.
- Started
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Jun 2017
- Finished
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Nov 2024
- Lead sponsor
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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
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40 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Henry Ford Hospital
Detroit, Michigan, 48202, United States
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601, United States
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
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