NCT02529384

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 20, 2015

Status Verified

August 1, 2015

Enrollment Period

4.8 years

First QC Date

June 16, 2015

Last Update Submit

August 18, 2015

Conditions

Breast NeoplasmsDWI

Keywords

Breast magnetic resonance imagingDiffusion-weighted imagingMultiple b-value diffusion weighted imaging

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (3)

  • Value of intraclass correlation coefficient (ICC) within inter-observe and intra-observe

    From 92 week to 120 week.

  • The true-positive and true-negative rates for each parameter

    From 92 week to 120 week.

  • The values of R and P for Pearson Correlation analyses between DWI parameters and molecular/morphological markers

    From 120 week to 130 week.

Study Arms (3)

malignant group

The lesion which is malignant tumors in breast

Other: Breast magnetic resonance scanning

begin group

The lesion which is begin lesion in breast

Other: Breast magnetic resonance scanning

The control group

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

Other: Breast magnetic resonance scanning

Interventions

Breast magnetic resonance scanningOTHER

Just a muti-b value series in breast MRI

The control groupbegin groupmalignant group

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with brest lesions.

You may qualify if:

  • Female patient with breast lesion (Breast Imaging Reporting and Data System 2,3,4,5)
  • Operation is take in Tang-du hospital

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tang-Du Hospital

Xi’an, Shanxi, China

RECRUITING

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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bao Ying Chen, M . D .

    Radiology department of Tang-Du hosipital

    STUDY DIRECTOR

Central Study Contacts

Bao Ying Chen, M . D .

CONTACT

18629527901chenby128@163.com

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2015

First Posted

August 20, 2015

Study Start

January 1, 2015

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

August 20, 2015

Record last verified: 2015-08

Locations

CN(1)