Breast CarcinomaNCT03220893
Molecular Breast Imaging and Digital Breast Tomosynthesis in Screening Patients With Dense Breast Tissue
A study testing Digital Breast Tomosynthesis (DBT) and Scintimammography in people with Breast Carcinoma, run by Mayo Clinic at 5 sites in United States.
Trial summary
This study compares molecular breast imaging (MBI) and digital breast tomosynthesis (DBT) in screening patients with dense breast tissue. Breast imaging may help doctors find breast cancer sooner, when it may be easier to treat. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Digital Breast Tomosynthesis (DBT) and Scintimammography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,023 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Jun 2017to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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])
Show all 12Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Henry Ford Hospital
Detroit, Michigan, 48202
M D Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623
About this study
Official title: Density MATTERS [Molecular Breast Imaging (MBI) And Tomosynthesis To Eliminate the ReServoir]
This study compares molecular breast imaging (MBI) and digital breast tomosynthesis (DBT) in screening patients with dense breast tissue. Breast imaging may help doctors find breast cancer sooner, when it may be easier to treat. Molecular breast imaging (MBI) uses an injection of a small amount of radioactive material that is taken up in tissues of the body that are actively changing, such as breast cancer. A specialized camera, called a gamma camera, takes pictures of the gamma rays emitted by this material. MBI may detect cancers that are not visible on mammograms. This study may help researchers determine how MBI testing compares to DBT screening.
Read the detailed description
This study includes women age 40-75 who are presenting for breast cancer screening and had mammographically dense breasts on their last mammogram. Participants undergo annual DBT and MBI screening for two years. The primary aim for this study is to compare the rate of detection of invasive cancers between DBT alone vs. the combination of DBT with supplemental MBI at the first year of screening.
- Conditions
- Breast Carcinoma
- Being tested
- Digital Breast Tomosynthesis (DBT), Scintimammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Breast Tomosynthesis (DBT)Procedure or surgery
Also called DBT, Digital Breast Tomosynthesis, Digital Tomosynthesis Mammography, Digital Tomosynthesis of the Breast
DBT is standard of care breast screening
ScintimammographyRadiation
Also called Breast-Specific Gamma Imaging, MBI, Miraluma Scan, Miraluma Test
Undergo MBI
| Study group | Role | What they receive |
|---|---|---|
| DBT alone | Experimental | All participants undergo DBT screening Receives: Procedure: Digital Breast Tomosynthesis (DBT) |
| DBT + MBI | Experimental | All participants undergo DBT screening + supplemental MBI Receives: Procedure: Digital Breast Tomosynthesis (DBT); Radiation: Scintimammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Detection of Invasive Cancers
Compare the rate of detection of invasive cancers between DBT alone versus (vs.) the combination of digital breast tomosynthesis (DBT) with supplemental molecular breast imaging (MBI) at initial (year 1) screening. For each modality, the detection rate of invasive cancers will be estimated as the proportion of participants in the analysis set who had an invasive cancer detected by the modality and verified by pathology.
Measured: At year 1 screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start14 Jun 2017
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,023 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Carrie B. Hruska, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220893
- Sponsor's protocol ID
- 16-008522
- Other IDs
- R01CA239200, NCI-2021-12015
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2017
- Last updated
- 24 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Density MATTERS [Molecular Breast Imaging (MBI) And Tomosynthesis To Eliminate the ReServoir]
- ClinicalTrials.gov ID
- NCT03220893
- Acronym / sponsor ID
- 16-008522
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,023 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, National Cancer Institute (NCI)
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 18 Jul 2017 (actual)
- Results
- Posted 3 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares molecular breast imaging (MBI) and digital breast tomosynthesis (DBT) in screening patients with dense breast tissue. Breast imaging may help doctors find breast cancer sooner, when it may be easier to treat. Molecular breast imaging (MBI) uses an injection of a small amount of radioactive material that is taken up in tissues of the body that are actively changing, such as breast cancer. A specialized camera, called a gamma camera, takes pictures of the gamma rays emitted by this material. MBI may detect cancers that are not visible on mammograms. This study may help researchers determine how MBI testing compares to DBT screening.
Detailed description
This study includes women age 40-75 who are presenting for breast cancer screening and had mammographically dense breasts on their last mammogram. Participants undergo annual DBT and MBI screening for two years. The primary aim for this study is to compare the rate of detection of invasive cancers between DBT alone vs. the combination of DBT with supplemental MBI at the first year of screening.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBT alone | Experimental | Procedure: Digital Breast Tomosynthesis (DBT)All participants undergo DBT screening |
| DBT + MBI | Experimental | Procedure: Digital Breast Tomosynthesis (DBT), Radiation: ScintimammographyAll participants undergo DBT screening + supplemental MBI |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Breast Tomosynthesis (DBT)Also: DBT, Digital Breast Tomosynthesis, Digital Tomosynthesis Mammography, Digital Tomosynthesis of the BreastDBT is standard of care breast screening | Procedure or surgery | DBT + MBI, DBT alone |
| ScintimammographyAlso: Breast-Specific Gamma Imaging, MBI, Miraluma Scan, Miraluma TestUndergo MBI | Radiation | DBT + MBI |
Primary outcome
Rate of Detection of Invasive Cancers
Time frame: At year 1 screening
Compare the rate of detection of invasive cancers between DBT alone versus (vs.) the combination of digital breast tomosynthesis (DBT) with supplemental molecular breast imaging (MBI) at initial (year 1) screening. For each modality, the detection rate of invasive cancers will be estimated as the proportion of participants in the analysis set who had an invasive cancer detected by the modality and verified by pathology.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie B. Hruska, M.D. principal investigator
Mayo Clinic in Rochester
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Breast Tomosynthesis (DBT) and Scintimammography in people with Breast Carcinoma, run by Mayo Clinic at 5 sites 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 7 inclusion and 12 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: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 3 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Detection of Invasive Cancers (time frame: At year 1 screening). 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 24 Sep 2026.