Breast Cancer Clinical Trial

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

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.

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Full 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].

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Eligibility Criteria

Inclusion Criteria:

The subjects to be studied will include female patients ages 18 and older of any race, identified as carrying an elevated risk for breast cancer referred to MDACC.
High risk may be defined as having a calculated lifetime risk >20%, histopathology of lobular neoplasia or atypical ductal hyperplasia, atypia NOS or a genetic mutation known to predispose the patient to breast cancer.

Exclusion Criteria:

Subjects who are pregnant will be excluded as MBI exam involves injection of radioactive tracer
contrast enhanced MRI involves gadolinium injection, both of which are contraindicated during pregnancy.

Study is for people with:

Breast Cancer

Estimated Enrollment:

300

Study ID:

NCT05042687

Recruitment Status:

Recruiting

Sponsor:

M.D. Anderson Cancer Center

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There is 1 Location for this study

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M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Hannah L Chung
Contact
713-745-4555
[email protected]
Hannah L Chung, MD
Principal Investigator

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Study is for people with:

Breast Cancer

Estimated Enrollment:

300

Study ID:

NCT05042687

Recruitment Status:

Recruiting

Sponsor:


M.D. Anderson Cancer Center

How clear is this clinincal trial information?

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