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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Diagnostic (DCE-MRI, MBI) 		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).
  • Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
    Undergo DCE-MRI
    Other names:
    • DCE MRI
    • DCE-MRI
    • DYNAMIC CONTRAST ENHANCED MRI
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Radiation: Scintimammography
    Undergo MBI
    Other names:
    • Breast-Specific Gamma Imaging
    • MBI
    • Miraluma Scan
    • Miraluma Test
    • Molecular Breast Imaging
    • Nuclear Medicine Breast Imaging
    • sestamibi breast imaging
    • Sestamibi Scintimammography
  • Drug: Technetium Tc-99m Sestamibi
    Given via injection
    Other names:
    • Cardiolite
    • Miraluma
    • Tc 99m Sestamibi
    • Tc-99m MIBI
    • Tc99m Sestamibi

More Details

Status
Active, not recruiting
Sponsor
M.D. Anderson Cancer Center

Study Contact

Detailed Description

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.