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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.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02529384
Enrollment
100
Registered
2015-08-20
Start date
2015-01-31
Completion date
2019-12-31
Last updated
2015-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, DWI

Keywords

Breast magnetic resonance imaging, Diffusion-weighted imaging, Multiple b-value diffusion weighted imaging

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.

Interventions

OTHERBreast magnetic resonance scanning

Just a muti-b value series in breast MRI

Sponsors

Tang-Du Hospital
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 imageFrom first week to 92 weekParameters 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 positive rates of molecular markers from the immunohistochemistry sectionsFrom first week to 92 weekImmunohistochemistry 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 density measurement of microvessel density (MVD) and microlymphatic density (MLD)From first week to 92 weekMVD: the number of microvessels divided by the observing area; MLD: the number of lymphocytes divided by the observing area.

Secondary

MeasureTime frameDescription
Value of intraclass correlation coefficient (ICC) within inter-observe and intra-observeFrom 92 week to 120 week.The intraclass correlation coefficient(ICC) of inter-observe and intra-observe.
The true-positive and true-negative rates for each parameterFrom 92 week to 120 week.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.
The values of R and P for Pearson Correlation analyses between DWI parameters and molecular/morphological markersFrom 120 week to 130 week.Correlation coefficient of each MR and pathological/molecular-biological biomarkers.

Countries

China

Contacts

Primary ContactBao Ying Chen, M . D .
chenby128@163.com18629527901

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026