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Technetium Tc 99m Sestamibi

Radiopharmaceuticals

Participants undergo 3 MBI scans with injections of injection of Tc99m sestamibi before each scan. First scan is 7 days before scheduled chemotherapy treatment, after 2 cycles of chemotherapy, and after completion of chemotherapy treatment.

Participants undergo 3 MBI scans with injections of injection of Tc99m sestamibi before each scan. First scan is 7 days before scheduled neoadjuvant chemotherapy (NAC) treatment, after 2 cycles of chemotherapy, and after completion of chemotherapy treatment.

Molecular Breast Imaging (MBI)

8 mCi of 99mTc sestamibi by vein before each molecular breast imaging (MBI).

Tc99m sestamibi

Gaiane M. Rauch, MD, PHD

This clinical trial studies technetium Tc-99m sestamibi molecular breast imaging in predicting tumor response in patients with locoregional breast cancer that has spread from where it began in the breast to surrounding normal tissue who are receiving neoadjuvant chemotherapy. Comparing results of diagnostic procedures, such as technetium Tc-99m sestamibi molecular breast imaging, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

PRIMARY OBJECTIVE:

I. To evaluate the ability of technetium Tc-99m sestamibi (Tc 99m sestamibi) molecular breast imaging (MBI) to predict early response to neoadjuvant chemotherapy (NAC) and to assess residual disease at the completion of NAC in patients with locoregional invasive breast cancer.

SECONDARY OBJECTIVES:

I. To evaluate and qualitatively characterize Tc 99m sestamibi uptake by tumor on MBI at the baseline, after 2 cycles of NAC and at the completion of NAC.

II. To compare assessment of tumor response to NAC by MBI with digital mammography (DM), and breast ultrasound (US) exams.

III. To compare tumor size and distribution observed from MBI at the completion of NAC with extent of residual disease at surgery by pathological evaluation.

IV. To develop image acquisition and processing algorithm that quantifies the Tc 99m tumor uptake.

EXPLORATORY OBJECTIVE:

I. To determine effect of molecular subtype of cancer (Her2+, ER/PR/Her2- and ER+/Her2-) on diagnostic performance of MBI in predicting treatment response.

OUTLINE:

Patients undergo technetium Tc-99m sestamibi molecular breast imaging over 45 minutes at baseline (before start of NAC), after 2 courses of NAC (6-12 weeks, depending on the regimen), and the completion of NAC but before surgery. Patients also undergo breast ultrasound and mammographic imaging as standard of care at the same time points.

Tc99m Sestamibi Molecular Breast Imaging

Assessment of the Tumor Response to Neoadjuvant Chemotherapy in Women With Locoregional Invasive Breast Cancer Using Tc99m Sestamibi Molecular Breast Imaging: A Prospective Study

Evaluation of treatment response by molecular breast imaging (MBI) tumor to background ratio (T/B), defined as T/B = ROIt_max/ROIb_mean, calculated.

M.D. Anderson Cancer Center

Carcinoma

MBI uses an injection of a small amount of radioactive material called technetium99m (Tc99m) sestamibi

Tanya Moseley

Hannah L Chung

Hannah L Chung, MD

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.

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 \[1\].

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tc99m Sestamibi Molecular Breast Imaging	NCT02324387	Breast Cancer	Molecular Breas... Tc99m sestamibi	18 Years -	M.D. Anderson Cancer Center
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	NCT05042687	Breast Cancer	Tc99m sestamibi	18 Years -	M.D. Anderson Cancer Center
Tc99m Sestamibi Molecular Breast Imaging	NCT02324387	Breast Cancer	Molecular Breas... Tc99m sestamibi	18 Years -	M.D. Anderson Cancer Center

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