Multiple B-value Diffusion-weighted Imaging in Evaluation of Breast Lesions：Compare Biexponential Model, Stretched Exponential Model, Conventional Monoexponential DWI and Pathological Specimens.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Neoplasms
- Sponsor
- Tang-Du Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The positive rates of molecular markers from the immunohistochemistry sections
- Last Updated
- 10 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
The positive rates of molecular markers from the immunohistochemistry sections
Time Frame: From first week to 92 week
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.
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
Time Frame: From first week to 92 week
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).
The density measurement of microvessel density (MVD) and microlymphatic density (MLD)
Time Frame: From first week to 92 week
MVD: the number of microvessels divided by the observing area; MLD: the number of lymphocytes divided by the observing area.
Secondary Outcomes
- The true-positive and true-negative rates for each parameter(From 92 week to 120 week.)
- Value of intraclass correlation coefficient (ICC) within inter-observe and intra-observe(From 92 week to 120 week.)
- The values of R and P for Pearson Correlation analyses between DWI parameters and molecular/morphological markers(From 120 week to 130 week.)