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Evaluation of Low-dose Molecular Breast Imaging as a Screening Tool in Women With Mammographically Dense Breasts and Increased Risk of Breast Cancer


N/A
40 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Evaluation of Low-dose Molecular Breast Imaging as a Screening Tool in Women With Mammographically Dense Breasts and Increased Risk of Breast Cancer


The sensitivity of conventional mammography (MMO) is poor in women with mammographically
dense breast parenchyma. We have developed Molecular Breast Imaging (MBI) - a new technique
which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography that has a
high sensitivity (~90%) for the detection of breast cancers independent of breast density.

The aim of this study is to demonstrate the utility of MBI as an adjunct screening modality
for the detection of occult breast cancers in women with mammographically dense breast
tissue. The study will comprise 3500 women. Initial recruitment will be from the pool of
patients awaiting a screening mammogram in the Department of Radiology at Mayo Clinic
Rochester. All patients will have a screening MMO and an MBI study. Patients with positive
studies (MBI or MMO) will undergo additional diagnostic studies. At 15 months
post-recruitment, all patients will be contacted by phone or mail to determine whether
subsequent to their study, there has been any change in their breast status.


Inclusion Criteria:



- Past prior SM interpreted as negative or benign (MUST BE PREFORMED AT MAYO CLINIC
ROCHESTER)

- Past prior SM interpreted as heterogeneously dense or extremely dense (MUST BE
PREFORMED AT MAYO CLINIC ROCHESTER)

- Age 40 or older

Exclusion Criteria:

- They are unable to understand and sign the consent form

- They are pregnant or lactating

- They are physically unable to sit upright and still for 40 minutes.

- They have self-reported signs or symptoms of breast cancer (palpable mass, bloody
nipple discharge, axillary mass etc.).

- They have had needle biopsy within 3 months, or breast surgery within 1 year prior to
the study.

- They are currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor
for adjuvant therapy or chemoprevention.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Sensitivity of MBI relative to sensitivity of mammography

Outcome Time Frame:

Mammogram and MBI must be done within 30 days at Mayo Clinic Rochester

Safety Issue:

No

Principal Investigator

Deborah J. Rhodes, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

1337-05

NCT ID:

NCT00620373

Start Date:

August 2005

Completion Date:

September 2012

Related Keywords:

  • Breast Cancer
  • Dense breast tissue
  • Breast Cancer Screening
  • Molecular Breast Imaging
  • Breast Cancer
  • Breast
  • Breast Neoplasms

Name

Location
Mayo Clinic Rochester, Minnesota  55905