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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

Immune System Diseases

Hypersensitivity

CZT semiconductor detectors

Michael K. O'Connor, Ph.D.

Deborah J. Rhodes, M.D.

Douglas A. Collins, M.D.

Carrie B. Hruska, Ph.D.

This study is being done to test the ability of an investigational mammography camera to find small tumors in patients' breasts.

If you agree to take part in this study, you will be asked to remove your clothes from the waist up and put on a gown. A female technologist will give you an injection of Tc-99m sestamibi in a vein in your arm. This is a drug routinely used for breast imaging. About 10 minutes after your injection, you will be asked to sit in a chair for about 40 minutes. The technologist will position your breast between two small cameras. The cameras will apply a very light compression to your breast to make sure there is no movement during the picture. We will take two pictures of each breast. Each picture takes 10 minutes. You will also be asked to fill out a short questionnaire. If you are found to have additional breast lesions, your doctor and radiologist will be notified so that additional imaging or biopsies can be performed.

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
Pre-biopsy With Dynamic Acquisitions	NCT00943644	Breast Cancer	Molecular Breas... CZT semiconduct...	18 Years -	Mayo Clinic
Tc99m Sestamibi Molecular Breast Imaging	NCT02324387	Breast Cancer	Molecular Breas... Tc99m sestamibi	18 Years -	M.D. Anderson Cancer Center
Pre-biopsy With Dynamic Acquisitions	NCT00943644	Breast Cancer	Molecular Breas... CZT semiconduct...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for molecular breast imaging (mbi)