DCE-MRI and MBI in Assessing Tumor Response to Chemotherapy in Patients With Triple Negative Breast Cancer
DCE-MRI and MBI in Assessing Tumor Response to Chemotherapy in Patients With Triple Negative Breast Cancer
This early phase I trial studies how well dynamic contrast enhanced molecular resonance
 imaging (DCE-MRI) and technetium-Tc99m sestamibi molecular breast imaging (MBI) work in
 assessing tumor response to chemotherapy in patients with triple negative breast cancer
 (TNBC) who are undergoing chemotherapy. Investigational imaging scans such as MBI and DCE-MRI
 may help researchers predict which patients may respond to treatment.
PRIMARY OBJECTIVES:

 I. To determine the predictive value of advanced imaging modalities Tc99m sestamibi
 (technetium Tc-99m sestamibi) molecular breast imaging (MBI) and dynamic contrast enhanced
 (DCE) magnetic resonance imaging (MRI) for neoadjuvant chemotherapy (NAC) response in triple
 negative breast cancer (TNBC).

 SECONDARY OBJECTIVES:

 I. To evaluate and compare the ability all imaging modalities including standard of care
 digital mammogram (DM) and ultrasound (US) as well as novel modalities DCE-MRI and MBI to
 assess and predict response to neoadjuvant chemotherapy (NAC) in patients with triple
 negative breast cancer (TNBC).

 EXPLORATORY OBJECTIVES:

 I. To determine effect of molecular subtype of TNBC on diagnostic performance of different
 types of imaging modalities in predicting treatment response.

 II. To determine the Utility of Dynamic Tc99m sestamibi MBI and DCE-MRI together with
 molecular profiling to identify a subgroup of chemoresistant TNBC patients.

 OUTLINE:

 Patients undergo DCE-MRI over 45-60 minutes. Patients receive technetium Tc-99m sestamibi via
 injection, and after 5 minutes patients undergo MBI scan over 1 hour. Both DCE-MRI and MBI
 are performed at the time of enrollment, at the end of anthracycline therapy, and at the
 conclusion of NAC before surgery. All patients also undergo standard of care imaging with DM
 and US (at the same time points if the treating doctor chooses to do so).
Inclusion Criteria:

 -  The patient has proven TNBC, defined by standard pathologic assays as negative for
 estrogen receptor (ER) and progesterone receptor (PR) (< 10% tumor staining) and
 negative for human epidermal growth factor 2 (HER2) (immunohistochemistry [IHC] score
 < 3, gene copy number not amplified)

 -  TNBC patients who are previously untreated and enrolled in the prospective
 Institutional Review Board (IRB) approved clinical trial: 2014-0185

 -  Patients who are able to understand and give consent to participating in the study

 Exclusion Criteria:

 -  Is pregnant (confirmed by the patient as imaging clinic standard of care) or nursing
 mother

 -  Has lesions involving chest wall

 -  Has known allergy to Tc99m sestamibi

 -  Has known contraindications to MRI

 -  Has contraindication to MRI contrast