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

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Procedure: Molecular Breast Imaging

• Registration Number: NCT01723124
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-24
• Study First Submitted QC: 2012-11-05
• Study First Posted: 2012-11-07
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 228

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]

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Molecular Breast Imaging	Molecular Breast Imaging	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Molecular Breast Imaging (MBI) scan	Performed at Year 2 of study	The Year 2 MBI will be interpreted in comparison with the Year 0 MBI but in isolation from the Year 2 mammogram.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States