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Active (not recruiting) Early Phase 1 NCT02744053

DCE-MRI and MBI in Assessing Tumor Response to Chemotherapy in Patients With Triple Negative Breast Cancer

Very early trial – mainly for safety
Conditions: Estrogen Receptor Negative HER2/Neu Negative Progesterone Receptor Negative Triple-Negative Breast Carcinoma

Sponsor: M.D. Anderson Cancer Center

trial.available_in: БГ
Overview
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.
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).
Who can participate
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
Interventions
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
PROCEDURE
Laboratory Biomarker Analysis
OTHER
Scintimammography
RADIATION
Technetium Tc-99m Sestamibi
DRUG
Locations 6
United States (6)
Memorial Hermann Memorial City Medical Center
Houston , Texas
M D Anderson Cancer Center
Houston , Texas
MD Anderson in Katy
Houston , Texas
MD Anderson League City
Nassau Bay , Texas
MD Anderson in Sugar Land
Sugar Land , Texas
MD Anderson in The Woodlands
The Woodlands , Texas
Technical details
Status
Active (not recruiting)
Phase
Early Phase 1
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Healthy volunteers
No
Start date
07.11.2016
Completion date
30.04.2028
Registry ID
NCT02744053
Source
clinicaltrials.gov
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