PET-MR for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is: To validate the efficacy of multiparametric MRI, FDG-PET, RGD-PET, and PET-MR fusion imaging in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients. To identify the optimal combination parameters of MR spectroscopy, diffusion-weighted MRI, dynamic contrast-enhanced MRI, FDG-PET, and RGD-PET in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients. To compare the performances of dynamic contrast-enhanced MRI using parametric response map analysis versus those of pharmacokinetic parameters (Ktrans, kep, or Ve) in the early prediction of pathological responsiveness to neoadjuvant chemotherapy in breast cancer patients

Detailed Description
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Enrolled women with breast cancers who had received an anthracycline-taxane regimen and subsequent surgery were prospectively enrolled. DCE-MRI and FDG-PET scan were performed before and after the 1st cycle of chemotherapy. MR imaging parameters and SUV on PET scan within a tumor were analyzed. Clinicopathologic (age, clinical tumor stage, hormonal receptor status, and surgery type) and imaging parameters were compared according to the pathological response.

Official Title
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PET-MR Fusion Imaging and Surrogate Marker for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer Patients

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed breast cancer Clinical stage IIb, IIIa, IIIb, IIIc Must have measurable disease Performance status of ECOG 0-2 Adequate, bone marrow, liver, heart, and renal function Who did not receive chemotherapy for breast cancer Must agree with and signed informed consent Exclusion Criteria: Prior history of cancer besides breast cancer Active bacterial infection Pregnant or lactating women Psychological disease or seizure History of arrhythmia, congestive heart failure, myocardial infarct, or unstable angina Male breast cancer Who had a pacemaker or history of open heart surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patholocial Response to Chemotherapy | Pathological complete response (pCR) or non-pCR | Post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Size | Maximal tumor diameter measured on magnetic resonance imaging | baseline, completion of 1st cycle of chemotherapy | 
| Tumor Volume | Tumor volume measured on 3-dimensional magnetic resonance imaging | Baseline, post-1st chemotherapy | 
| Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI) | Parametric response map analysis using a software calculates the interval change of signal intensity based on a voxel-to-voxel comparison between measurements at baseline and after the first cycle of chemotherapy. PRMSI+ indicates proportions of voxels within a tumor with increased signal intensity. PRMSI- indicates proportions of voxels within a tumor with decreased signal intensity. PRMSI0 indicates proportions of voxels within a tumor with unchanged signal intensity. | Baseline, post-1st chemotherapy | 
| Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans) |  | Baseline, post-1st chemotherapy | 
| Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep) |  | Baseline, post-1st chemotherapy | 
| Extracellular Extravascular Space Per Unit Volume of Tissue (Ve) |  | Baseline, post-1st chemotherapy | 
| Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy | Single voxel 1H-magnetic resonance spectroscopy quantifies the amount of total choline-containing compounds of a tumor, which indicates cellular proliferation and malignant transformation. | Baseline, post-1st chemotherapy | 
| Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography |  | Baseline, post-1st chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic Resonance Imaging, Functional, Tomography, Positron-Emission, chemotherapy