Multiple B-value Diffusion-weighted Imaging(DWI) in Evaluation of Breast Lesions

Study Overview
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Brief Summary
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Breast cancer is the most commonly diagnosed cancer in women and its definite diagnose is still challenge for radiologist. This study is going to evaluate multi-b value diffusion weighted imaging in discrimination of breast benign and malignant lesions and explore the diagnostic effect of the combination of multi-parameter. At the same time, pathological specimens of patients will be collected. The relationship between magnetic resonance(MR) parameters and pathology biomarkers will be evaluated. Hope multi-b value diffusion weighted imaging can improve diagnosis for breast lesion and provide the basis for clinical treatment. The fundamental of pathology on MR signal change will be further expounded.

Detailed Description
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Breast cancer is the most commonly diagnosed cancer in women and its definite diagnose is still challenge for radiologist. This study is going to evaluate multi-b values diffusion weighted imaging in discrimination of breast benign and malignant lesions and explore the diagnostic effect of the combination of multi-parameters. At the same time, pathological specimens of patients will be collected. The relationship between MR parameters and pathology biomarkers will be evaluated. By pre-contrast and post-contrast multi-b values diffusion weighted imaging series, patient's Apparent diffusion coefficient(ADC),tissue diffusivity (D), pseudo-diffusion coefficient (D*), perfusion fraction (f), distributed diffusion coefficient(DDC) and alpha will be evaluated. Parameters of benign , malignant breast lesions and ipsilateral or contralateral normal breast parenchyma as a control group will be measured. Receiver operating characteristic (ROC) curve analysis is used to test the ability of different parameters in differentiating malignant from begin lesions. After Surgical operation, specimen of lesion will be collected(Not every patient's specimen will be collected. The investigators should be approved by patient themselves). The biomarkers of specimen will be detected by pathological and molecular-biological methods.Then analyze the relation between parameters of the MR imaging and pathological/molecular-biological biomarkers.

Official Title
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Multiple B-value Diffusion-weighted Imaging in Evaluation of Breast Lesions：Compare Biexponential Model, Stretched Exponential Model, Conventional Monoexponential DWI and Pathological Specimens.

Conditions
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Breast Neoplasms, DWI

Intervention / Treatment
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* Other: Breast magnetic resonance scanning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patient with breast lesion (Breast Imaging Reporting and Data System 2,3,4,5) Operation is take in Tang-du hospital Exclusion Criteria: Postoperative patient Suffer radiotherapy,chemotherapy and endocrine treatment Serious image artifacts Lesion with diameter less than 3mm Scan during menstrual period Other magnetic resonance imaging contraindications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| malignant group<br>The lesion which is malignant tumors in breast | Other: Breast magnetic resonance scanning<br>* Just a muti-b value series in breast MRI<br>|
| begin group<br>The lesion which is begin lesion in breast | Other: Breast magnetic resonance scanning<br>* Just a muti-b value series in breast MRI<br>|
| The control group<br>Patient's ipsilateral or contralateral normal breast parenchyma were collected as a control group | Other: Breast magnetic resonance scanning<br>* Just a muti-b value series in breast MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The values of Apparent diffusion coefficient (ADC, mm^2/s), tissue diffusivity (D, mm^2/s), pseudo-diffusion coefficient (D*, mm^ 2/s) measured from the DWI image | Parameters of multiple b-value and conventional DWI: ADC (mm^2/s), D (mm^2/s), D* (mm^2/s), distributed diffusion coefficient (DDC, mm^2/s). | From first week to 92 week | 
| The positive rates of molecular markers from the immunohistochemistry sections | Immunohistochemistry index (immunopositive rate, calculated with the numbers of positively labeled cells [2 fold increase vs the background] divided by the number of total cells) for estrogen receptor (ER), progesterone receptor(PR), Ki-67 (KI-67), Her 2 and Aquaporins. | From first week to 92 week | 
| The density measurement of microvessel density (MVD) and microlymphatic density (MLD) | MVD: the number of microvessels divided by the observing area; MLD: the number of lymphocytes divided by the observing area. | From first week to 92 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of intraclass correlation coefficient (ICC) within inter-observe and intra-observe | The intraclass correlation coefficient(ICC) of inter-observe and intra-observe. | From 92 week to 120 week. | 
| The true-positive and true-negative rates for each parameter | The true-positive, false-positve,true-negative and false negative rates for each paramter are first calculated. Then the diagonistic sensitivity and specificity of each parameter are decided. | From 92 week to 120 week. | 
| The values of R and P for Pearson Correlation analyses between DWI parameters and molecular/morphological markers | Correlation coefficient of each MR and pathological/molecular-biological biomarkers. | From 120 week to 130 week. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast magnetic resonance imaging, Diffusion-weighted imaging, Multiple b-value diffusion weighted imaging