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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Mayo Clinic
Study ID
NCT03220893
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Digital Breast Tomosynthesis (DBT) — PROCEDURE
    DBT is standard of care breast screening
  • Scintimammography — RADIATION
    Undergo MBI

Study Details

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.

Key Dates

Start date
Jun 14, 2017
Status verified
Jan 2026
Primary completion
Sep 30, 2024
Completion
Nov 1, 2024

Study Design

Enrollment
3,023 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: DBT alone
    All participants undergo DBT screening
  • Experimental: DBT + MBI
    All participants undergo DBT screening + supplemental MBI

Primary Outcome Measure

Rate of Detection of Invasive Cancers [ Time Frame: At year 1 screening ]

Locations (5)

FacilityCityStateZIPSite coordinators
Henry Ford HospitalDetroitMichigan48202-
Mayo Clinic in RochesterRochesterMinnesota55905-
Toledo Clinic Cancer Centers-ToledoToledoOhio43623-
M D Anderson Cancer CenterHoustonTexas77030-
Mayo Clinic Health System-Franciscan HealthcareLa CrosseWisconsin54601-

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