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Trial record 21 of 32058 for:    value

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

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ClinicalTrials.gov Identifier: NCT02529384
Recruitment Status : Recruiting
First Posted : August 20, 2015
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Tang-Du Hospital

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.

Condition or disease Intervention/treatment
Breast Neoplasms DWI 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Prospective
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 Start Date : January 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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 Outcome Measures :
  1. Value of intraclass correlation coefficient (ICC) within inter-observe and intra-observe [ Time Frame: From 92 week to 120 week. ]
    The intraclass correlation coefficient(ICC) of inter-observe and intra-observe.

  2. The true-positive and true-negative rates for each parameter [ Time Frame: From 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.

  3. The values of R and P for Pearson Correlation analyses between DWI parameters and molecular/morphological markers [ Time Frame: From 120 week to 130 week. ]
    Correlation coefficient of each MR and pathological/molecular-biological biomarkers.


Biospecimen Retention:   Samples With DNA
After Surgical operation, specimen of lesion will be collected(Not every patient's specimen will be collected. We should be approved by patient themselves). For analyze the relation with biomarker from the MR imaging and pathological/molecular-biological biomarkers.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with brest lesions.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529384


Contacts
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Contact: Bao Ying Chen, M . D . 18629527901 chenby128@163.com

Locations
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China, Shanxi
Tang-Du Hospital Recruiting
Xi An, Shanxi, China
Contact: Xie Zhuo, MM    18706798191      
Sponsors and Collaborators
Tang-Du Hospital
Investigators
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Study Director: Bao Ying Chen, M . D . Radiology department of Tang-Du hosipital

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Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT02529384     History of Changes
Other Study ID Numbers: TDLL-2015128
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015

Keywords provided by Tang-Du Hospital:
Breast magnetic resonance imaging
Diffusion-weighted imaging
Multiple b-value diffusion weighted imaging

Additional relevant MeSH terms:
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Breast Neoplasms
Body Weight
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms