CompletedNCT03220893Updated Sep 24, 2026Results posted

Molecular Breast Imaging and Digital Breast Tomosynthesis in Screening Patients With Dense Breast Tissue

An interventional study of Digital Breast Tomosynthesis (DBT) and Scintimammography in Breast Carcinoma, sponsored by Mayo Clinic. Completed at 5 sites in United States. Open to female participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic

Phase: Not applicable
Study type: Interventional
Enrollment: 3,023
Allocation: Non-randomized
Ages: 40 Years to 75 Years
Sex: Female

Study 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. 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 studied

Breast Carcinoma

Browse trials for

Breast Neoplasms 12,543

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 3,023 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

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Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 75 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 3,023 participants (actual)

Study arms

Experimental
DBT alone
All participants undergo DBT screening
Procedure: Digital Breast Tomosynthesis (DBT)
Experimental
DBT + MBI
All participants undergo DBT screening + supplemental MBI
Procedure: Digital Breast Tomosynthesis (DBT) · Radiation: Scintimammography

Interventions

ProcedureDigital Breast Tomosynthesis (DBT)
DBT is standard of care breast screening
Also known as: DBT, Digital Breast Tomosynthesis, Digital Tomosynthesis Mammography, Digital Tomosynthesis of the Breast
RadiationScintimammography
Undergo MBI
Also known as: Breast-Specific Gamma Imaging, MBI, Miraluma Scan, Miraluma Test, Molecular Breast Imaging, Nuclear Medicine Breast Imaging, sestamibi breast imaging, Sestamibi Scintimammography

What researchers measure

Primary outcomes

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.
Time frame: At year 1 screening

Results

Posted Feb 3, 2026

Participant flow

Enrollment occurred from June 2017 to July 2022 through consecutive sampling.

DBT Alone

Participant flow — DBT Alone
Milestone	All Participants
Started	2978
Completed	2978
Not completed	0

DBT + MBI

Participant flow — DBT + MBI
Milestone	All Participants
Started	2978
Completed	2978
Not completed	0

Outcome measures

PrimaryRate 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.

Time frame:: At year 1 screening
Reported as:: Count of participants · Participants

Rate of Detection of Invasive Cancers
Participants	Observational (MBI, DBT)
Invasive cancers detected by DBT alone	9
Additional invasive cancers detected by supplemental MBI	14

Adverse events

Collected over 365 days after screening. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
All Participants	0/2,978 (0%)	0/2,978 (0%)	0/2,978 (0%)

Baseline characteristics

2978 participants met eligibility criteria and had both DBT and MBI screening performed

Age, Continuous
Age, Continuous(years)	All Participants
Mean	56.8 ± 9.3

Sex: Female, Male
Sex: Female, Male(Participants)	All Participants
Female	2978
Male	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	All Participants
American Indian or Alaska Native	7
Asian	59
Native Hawaiian or Other Pacific Islander	0
Black or African American	268
White	2592
More than one race	4
Unknown or Not Reported	48

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	All Participants
Hispanic or Latino	77
Not Hispanic or Latino	2833
Unknown or Not Reported	68

Study locations

5 sites

Henry Ford Hospital
Detroit, Michigan 48202, United States
Mayo Clinic in Rochester
Rochester, Minnesota 55905, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio 43623, United States
M D Anderson Cancer Center
Houston, Texas 77030, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin 54601, United States

References and documents

Study documents

Protocol and statistical analysis plan · Mar 19, 2025
Informed consent form · Feb 3, 2022

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03220893
Lead sponsor: Mayo Clinic
Collaborators: Susan G. Komen Breast Cancer Foundation, National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Jul 18, 2017
Start date: Jun 14, 2017
Primary completion: Jun 30, 2025
Completion: Jun 30, 2025
Results posted: Feb 3, 2026
Last update: Sep 24, 2026

Study contacts

Carrie B. Hruska, M.D.

principal investigator · Mayo Clinic in Rochester

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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