Low-dose Molecular Breast Imaging: Comparison of Breast Cancer Detection Rate at Initial Screening and Two-year Follow-up

Mayo Clinic

Status: Terminated

Conditions: Breast Cancer

Treatments: Procedure: Molecular Breast Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01723124

12-004322

Details and patient eligibility

About

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.

Enrollment: 228 patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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228 participants in 1 patient group

Molecular Breast Imaging

Experimental group

Description:

Molecular Breast Imaging (MBI) utilizes small high resolution gamma camera detectors in a dual-detector configuration to image the breast following the administration of a radiopharmaceutical that accumulates preferentially in breast tumors.

Treatment:

Procedure: Molecular Breast Imaging