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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


N/A
40 Years
80 Years
Open (Enrolling by invite only)
Female
Breast Cancer

Thank you

Trial Information

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


Inclusion Criteria:



1)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:

1. Are unable to understand and sign the consent form

2. Are pregnant or lactating

3. Are physically unable to sit upright and still for 40 minutes

4. Have self-reported signs or symptoms that may suggest breast cancer (palpable mass,
bloody nipple discharge, axillary mass, etc.)

5. Have had needle biopsy within 3 months, or breast surgery or radiation within 1 year
prior to the study

6. Are currently receiving chemotherapy or tamoxifen, raloxifene, or an aromatase
inhibitor for adjuvant therapy or chemoprevention

7. Have undergone bilateral mastectomy

8. Have had a prior MBI within 20 months of scheduled study MBI.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Outcome Measure:

• Molecular Breast Imaging (MBI) scan

Outcome Description:

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

Outcome Time Frame:

Performed at Year 0 of study

Safety Issue:

No

Principal Investigator

Deborah Rhodes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

12-004322

NCT ID:

NCT01723124

Start Date:

July 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • Dense breast tissue
  • breast cancer screening
  • molecular breast imaging
  • breast cancer
  • breast
  • Breast Neoplasms

Name

Location
Mayo Clinic in Rochester Rochester, Minnesota  55905