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

Breast Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02529384
• Other study ID #: TDLL-2015128
• Status: Recruiting
• Phase: N/A
• First received: June 16, 2015
• Last updated: August 18, 2015
• Start date: January 2015
• Est. completion date: December 2019

Study information

• Verified date: August 2015
• Source: Tang-Du Hospital
• Contact: Bao Ying Chen, M . D .
• Phone: 18629527901
• Email: chenby128[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• DWI

Intervention

Other:
• Breast magnetic resonance scanning
Just a muti-b value series in breast MRI

Locations

Country	Name	City	State
China	Tang-Du Hospital	Xi An	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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.	Yes
Secondary	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.	Yes
Secondary	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.	Yes