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Clinical Trials/NCT01723124
NCT01723124TerminatedNot Applicable

Comparison of Breast Cancer Detection Rate for Prevalent Screen Low-dose Molecular Breast Imaging and Incident Biennial Screen Low-dose Molecular Breast Imaging in Women With Mammographically Dense Breasts

Mayo Clinic2 sites in 1 country228 target enrollmentStarted: July 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
228
Locations
2
Primary Endpoint
Molecular Breast Imaging (MBI) scan
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this research is to evaluate whether repeating a screening Molecular Breast Imaging (MBI) study two years after an initial screening MBI study further improves breast cancer detection in women with dense breast tissue.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
Single (Investigator)

Eligibility Criteria

Ages
40 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Past prior screening mammogram within the previous 11-24 months interpreted as heterogeneously dense or extremely dense and negative or benign [Breast Imaging Reporting and Data System (BI-RADS) Category 1 or 2]

Exclusion Criteria

  • •Subjects will be excluded if they:
  • •Are unable to understand and sign the consent form
  • •Are pregnant or lactating
  • •Are physically unable to sit upright and still for 40 minutes
  • •Have self-reported signs or symptoms that may suggest breast cancer (palpable mass, bloody nipple discharge, axillary mass, etc.)
  • •Have had needle biopsy within 3 months, or breast surgery or radiation within 1 year prior to the study
  • •Are currently receiving chemotherapy or tamoxifen, raloxifene, or an aromatase inhibitor for adjuvant therapy or chemoprevention
  • •Have undergone bilateral mastectomy
  • •Have had a prior MBI within 20 months of scheduled study MBI.

Outcomes

Primary Outcomes

Molecular Breast Imaging (MBI) scan

Time Frame: Performed at Year 0 of study

The Year 0 MBI will be interpreted in isolation, with the radiologist blinded to Year 0 mammogram results and all relevant clinical information.

Secondary Outcomes

  • Molecular Breast Imaging (MBI) scan(Performed at Year 2 of study)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Deborah Rhodes

MD

Mayo Clinic

Study Sites (2)

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