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

NCT03220893 | Completed Results

• 3 other identifiers: 16-008522R01CA239200NCI-2021-12015
• Study Type: interventional
• Target: 3,023
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  At year 1 screening

Study Arms (2)

DBT alone

EXPERIMENTAL

All participants undergo DBT screening

Procedure: Digital Breast Tomosynthesis (DBT)

DBT + MBI

EXPERIMENTAL

All participants undergo DBT screening + supplemental MBI

Procedure: Digital Breast Tomosynthesis (DBT); Radiation: Scintimammography

Interventions

Digital Breast Tomosynthesis (DBT) PROCEDURE

DBT is standard of care breast screening

Also known as: DBT, Digital Breast Tomosynthesis, Digital Tomosynthesis Mammography, Digital Tomosynthesis of the Breast

DBT + MBI; DBT alone

Scintimammography RADIATION

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

DBT + MBI

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Susan G. Komen Breast Cancer Foundation: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (5)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Toledo Clinic Cancer Centers-Toledo

Toledo, Ohio, 43623, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Carrie Hruska, PhD
• Organization: Mayo Clinic

hruska.carrie@mayo.edu

507-284-4399

Study Officials

• Carrie B. Hruska, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2017
• First Posted: July 18, 2017
• Study Start: June 14, 2017
• Primary Completion: September 30, 2024
• Study Completion: November 1, 2024
• Last Updated: February 20, 2026
• Results First Posted: February 3, 2026

Record last verified: 2026-01

Locations

US (5)