Clinical trial NCT03220893: Molecular Breast Imaging and Digital Breast Tomosynthesis in Screening Patients With Dense Breast Tissue
Official title: Density MATTERS [Molecular Breast Imaging (MBI) And Tomosynthesis To Eliminate the ReServoir]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
name: National Cancer Institute (NCI)
First posted: 2017-07-18
Enrollment: 3023
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: PRIMARY OBJECTIVE:

I. To compare the rate of detection of invasive cancers between digital breast tomosynthesis (DBT) alone versus (vs.) the combination of DBT with supplemental MBI at year 0 screening.

SECONDARY OBJECTIVES:

I. To compare the invasive cancer detection rates of DBT alone vs. MBI alone at year 0 screening.

II. To compare the screening performance metrics of sensitivity, specificity, recall rate, biopsy rate, positive predictive value and negative predictive value for DBT and MBI.

III. To compare tumor characteristics of all cancers (invasive and noninvasive) detected on DBT and MBI, including size, nodal status, and molecular subtype.

IV. To assess the reduction in advanced cancer rate with incorporation of MBI screening by comparing advanced cancer rate observed at year 1 screening relative to that at year 0.

V. To assess the rate of interval cancers with incorporation of MBI screening. VI. To examine the relative performance of DBT and MBI within subgroups categorized by breast cancer risk.

OUTLINE:

Participants undergo DBT and MBI at year 0 and year 1 screening.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of detection of invasive cancers
timeFrame: At year 0 screening
Secondary outcomes:
measure: Rate of detection of invasive cancers
timeFrame: At year 0 screening
measure: Screening performance metrics of sensitivity
timeFrame: At year 0 and year 1 screening
measure: Screening performance metrics of specificity
timeFrame: At year 0 and year 1 screening
measure: Screening performance metrics of recall rate
timeFrame: At year 0 and year 1 screening
measure: Screening performance metrics of biopsy rate
timeFrame: At year 0 and year 1 screening
measure: Screening performance metrics of positive predictive value and negative predictive value
timeFrame: At year 0 and year 1 screening
measure: Characteristics of all cancers (invasive and noninvasive) detected on DBT and MBI
timeFrame: At year 1 screening
measure: Change in advanced cancer rate with incorporation of MBI screening
timeFrame: At year 0 and year 1 screening
measure: Rate of interval cancers with incorporation of MBI screening
timeFrame: At year 0 and year 1 screening
measure: Relative performance of DBT and MBI within subgroups categorized by breast cancer risk
timeFrame: At year 0 and year 1 screening
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Toledo
country: United States
facility: Toledo Clinic Cancer Centers-Toledo
state: Ohio
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: La Crosse
country: United States
facility: Mayo Clinic Health System-Franciscan Healthcare
state: Wisconsin
Study officials:
affiliation: Mayo Clinic in Rochester
name: Carrie B. Hruska, M.D.
role: PRINCIPAL_INVESTIGATOR
References: