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

NCT ID: NCT02529384

Last Updated: 2015-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Breast Neoplasms DWI

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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malignant group

The lesion which is malignant tumors in breast

Breast magnetic resonance scanning

Intervention Type OTHER

Just a muti-b value series in breast MRI

begin group

The lesion which is begin lesion in breast

Breast magnetic resonance scanning

Intervention Type OTHER

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

Breast magnetic resonance scanning

Intervention Type OTHER

Just a muti-b value series in breast MRI

Interventions

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Breast magnetic resonance scanning

Just a muti-b value series in breast MRI

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bao Ying Chen, M . D .

Role: STUDY_DIRECTOR

Radiology department of Tang-Du hosipital

Locations

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Tang-Du Hospital

Xi’an, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bao Ying Chen, M . D .

Role: CONTACT

18629527901

Facility Contacts

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Xie Zhuo, MM

Role: primary

18706798191

Other Identifiers

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TDLL-2015128

Identifier Type: -

Identifier Source: org_study_id

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