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

Tang-Du Hospital

Status: Unknown

Conditions: Breast Neoplasms; DWI

Treatments: Other: Breast magnetic resonance scanning

Study type: Observational

Funder types: Other

Identifiers

NCT02529384

TDLL-2015128

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 3 patient groups

malignant group

Description:

The lesion which is malignant tumors in breast

Treatment:

Other: Breast magnetic resonance scanning

begin group

Description:

The lesion which is begin lesion in breast

Treatment:

Other: Breast magnetic resonance scanning

The control group

Description:

Patient's ipsilateral or contralateral normal breast parenchyma were collected as a control group

Treatment:

Other: Breast magnetic resonance scanning