Clinical Trials

Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts

Location:

Trial status:

Closed

Why is this study being done?

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.

Who is eligible to participate?

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.

Last updated: 05/08/2013

NCT ID:

NCT00620373