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

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Neoplasms; DWI
• Intervention / Treatment: Other: Breast magnetic resonance scanning

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Xi An, Shanxi, China
      • Recruiting
      • Tang-Du Hospital
      • Contact: Xie Zhuo, MM; Phone Number: 18706798191

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with brest lesions.

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Tang-Du Hospital
• Investigators: Study Director: Bao Ying Chen, M . D ., Radiology department of Tang-Du hosipital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: June 16, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 20, 2015

Study Record Updates

• Last Update Posted (Estimate): August 20, 2015
• Last Update Submitted That Met QC Criteria: August 18, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Breast magnetic resonance imaging; Diffusion-weighted imaging; Multiple b-value diffusion weighted imaging
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Body Weight
• Other Study ID Numbers: TDLL-2015128