Comparative Performance of Molecular Breast Imaging (MBI) to Magnetic Resonance Imaging (MRI) of the Breast in Identifying and Excluding Breast Carcinoma in Women at High Risk for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT05042687|
Recruitment Status : Not yet recruiting
First Posted : September 13, 2021
Last Update Posted : September 21, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Tc99m sestamibi||Early Phase 1|
-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.
- 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 .
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Performance of Molecular Breast Imaging (MBI) to Magnetic Resonance Imaging (MRI) of the Breast in Identifying and Excluding Breast Carcinoma in Women at High Risk for Breast Cancer|
|Estimated Study Start Date :||September 30, 2021|
|Estimated Primary Completion Date :||January 31, 2023|
|Estimated Study Completion Date :||January 31, 2023|
Experimental: Tc99m sestamibi
MBI uses an injection of a small amount of radioactive material called technetium99m (Tc99m) sestamibi
Drug: Tc99m sestamibi
Given by IV
- To establish 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 [ Time Frame: through study completion, an average of 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05042687
|Contact: Hannah L Chung||(713) email@example.com|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Contact: Hannah L Chung 713-745-4555 firstname.lastname@example.org|
|Principal Investigator: Hannah L Chung, MD|
|Principal Investigator:||Hannah L Chung||M.D. Anderson Cancer Center|