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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Molecular Breast Imaging


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Molecular Breast Imaging<br>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. | Procedure: Molecular Breast Imaging<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular Breast Imaging (MBI) scan | The Year 0 MBI will be interpreted in isolation, with the radiologist blinded to Year 0 mammogram results and all relevant clinical information. | Performed at Year 0 of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular Breast Imaging (MBI) scan | The Year 2 MBI will be interpreted in comparison with the Year 0 MBI but in isolation from the Year 2 mammogram. | Performed at Year 2 of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast, Dense breast tissue, breast cancer screening, molecular breast imaging, breast cancer