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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

A new test for breast cancer screening, molecular breast imaging (MBI) may be more sensitive than mammography for detecting breast cancer in women with dense breasts. The purpose of this study is to see if MBI using a low dose of gamma radiation can find cancers not seen on mammography.

Hypotheses: 1. Low-Dose MBI has a significantly higher sensitivity and specificity and equal or higher positive predictive value than SM in women age 40 and older with mammographically dense breasts. 2. Low-dose MBI has comparable sensitivity and specificity to that previously achieved with MBI using a higher dose of radiation. 3. MBI produces a low false positive rate (specificity >90%) that permits its use as a screening tool in this patient population.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: Susan G. Komen Breast Cancer Foundation
• Treatments: Technetium Tc 99m Sestamibi

Criteria

Inclusion Criteria:

• Past prior SM interpreted as negative or benign [Breast Imaging Reporting and Data System (BI-RADS) Category 1 or 2]

• Past prior SM interpreted as heterogeneously dense or extremely dense

Exclusion Criteria:

• Subject is unable to understand and sign the consent form

• Subject is pregnant or lactating

• Subject is physically unable to sit upright and still for 40 minutes

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

• Subject has had needle biopsy within 3 months, or breast surgery within 1 year prior to the study

• Subject is currently taking tamoxifen, Evista (raloxifene), Zoladex or an aromatase inhibitor for adjuvant therapy or chemoprevention.