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Clinical Trial Summary

To evaluate the diagnostic performance of Tc99m sestamibi (MBI) compared to breast MRI in women who are at high risk for developing breast cancer. To assess the relationship of tumor size, histologic subtype and location of lesion and how it affects lesion conspicuity and sensitivity in MBI detected cancers.

Clinical Trial Description

Primary Objective: -To compare the diagnostic performance of Molecular Breast Imaging (MBI) to breast Magnetic Resonance Imaging (MRI) in women who are at high risk of developing breast cancer. Secondary Objectives: - To evaluate the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of MBI compared to breast MRI in women who are at high risk of developing breast cancer. - To assess patient preference for the two examinations by conducting a post examination survey and follow up questionnaire (see addendum). - To assess the relationship of tumor size, histologic subtype and location of lesion with lesion conspicuity (mild, moderate, marked uptake compared to background activity) according to MBI lexicon [1]. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05042687
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Hannah L Chung
Phone (713) 745-4555
Email [email protected]
Status Not yet recruiting
Phase Early Phase 1
Start date September 30, 2021
Completion date January 31, 2023

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