Clinical trial NCT02529384: Multiple B-value Diffusion-weighted Imaging(DWI) in Evaluation of Breast Lesions
Official title: Multiple B-value Diffusion-weighted Imaging in Evaluation of Breast Lesions：Compare Biexponential Model, Stretched Exponential Model, Conventional Monoexponential DWI and Pathological Specimens.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasms
DWI
Keywords: Breast magnetic resonance imaging
Diffusion-weighted imaging
Multiple b-value diffusion weighted imaging
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with brest lesions.

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.

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

Primary outcomes:
measure: 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
timeFrame: From first week to 92 week
measure: The positive rates of molecular markers from the immunohistochemistry sections
timeFrame: From first week to 92 week
measure: The density measurement of microvessel density (MVD) and microlymphatic density (MLD)
timeFrame: From first week to 92 week
Secondary outcomes:
measure: Value of intraclass correlation coefficient (ICC) within inter-observe and intra-observe
timeFrame: From 92 week to 120 week.
measure: The true-positive and true-negative rates for each parameter
timeFrame: From 92 week to 120 week.
measure: The values of R and P for Pearson Correlation analyses between DWI parameters and molecular/morphological markers
timeFrame: From 120 week to 130 week.
Other outcomes:
Locations:
city: Xi An
country: China
facility: Tang-Du Hospital
state: Shanxi
Study officials:
affiliation: Radiology department of Tang-Du hosipital
name: Bao Ying Chen, M . D .
role: STUDY_DIRECTOR
References: