Evaluation of Magnetic Resonance Imaging (MRI) vs Molecular Breast Imaging (Tc-MBI) in Breast Cancer Patients

Study Overview
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Brief Summary
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The objective of this study is to evaluate the usefulness of Tc-99m Sestamibi Molecular Breast Imaging as an imaging modality for breast cancer screening. Tc-MBI has shown significantly higher sensitivity and equivalent specificity in the detection of breast cancer among high risk women when compared to mammography. However, there is little published data comparing Tc-MBI to MRI for evaluating extent of disease in women with known breast cancer. The study will target twenty (20) women with newly diagnosed breast cancer who are scheduled to undergo biopsy of additional suspicious lesions that were identified on standard of care contrast- enhanced breast MRI. Prior to the biopsy, these subjects will receive a Tc-MBI scan of the breast. The results from both imaging methods will be compared to histological findings. These results may be used to design larger and more comprehensive studies with an overarching goal to determine if there is a role for Tc-MBI in the pre-operative evaluation of patients with known breast cancer.

Official Title
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Performance of Tc99m Sestamibi Molecular Breast Imaging (Tc-MBI) Versus Magnetic Resonance Imaging in the Diagnosis of Breast Carcinoma: A Pilot Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Sestamibi (Tc-MBI) scan of the breast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women Patients must be 18 years of age or older. Patients will have biopsy proven unilateral breast cancer with ipsilateral or contralateral suspicious lesions on contrast-enhanced breast MRI and be a candidate for additional tissue biopsy. Patients must be able to remain still for Tc-MBI scanning Patients must be able to provide written informed consent Exclusion Criteria: Men, age less than 18, inability to remain still for Tc-MBI scanning, cannot provide written informed consent, known untreated bilateral breast cancer, evidence of distant metastasis disease (M=1), pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sestamibi(Tc- MBI) scan of the breast<br> | Other: Sestamibi (Tc-MBI) scan of the breast<br>* Patients will be given 8mCi of Sestamibi intravenously. following which Sestamibi scan will be performed on the breast. Sestamibi scan will be done prior to any surgical procedure..<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer detection rates by Sestambi imaging | This study will determine whether Tc-MBI is useful in the pre-operative evaluation of patients with known breast cancer. Patients will be tracked for 2 years to see if histological evidence is found to confirm Tc-MBI findings | Up to 2 years |