MRCP Diagnoses EHCC Better When Combined DWI

May 14, 2017 updated by: Xiaoping Yang, China Medical University, China

The Incremental Value of 3T Diffusion-Weighted MRI in Diagnosing Extrahepatic Cholangiocarcinoma

Researching the diagnostic significance of Biliary Tract Neoplasm under combining DWI sequence with MRCP versus MRCP only separately.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of the study is to evaluate the usefulness of diffusion weighted imaging(DWI) combined with MRCP of 3.0T magnetic resonance imaging (MRI) in the evaluation of suspected malignant bile duct diseases. People with suspected Biliary Tract Neoplasm based on clinical symptoms (such as jaundice and thinness with unknown reasons) and CA-199 value raises are included.Diagnosis divided into two steps: the first one，only provide conventional MR sequences and MRCP images to make a diagnosis; the second step,provide the DWI images additionally, combining the image data before to make a diagnosis. Hypothesis is that DWI sequence should be regularly added into MRCP examination for improving diagnosis rate of Biliary Tract Neoplasm.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Room of 3.0TMR in the FAH of CMU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent
  • Suspected Biliary Tract Neoplasm based on clinical symptoms(such as jaundice and thinness with unknown reasons)and CA-199 raises（>37U/mL）
  • No evidence of clinical symptoms or CA-199 increase by non-bile duct cancerous factors(hepatitis,cholangeitis,stones)
  • Age ≥ 16

Exclusion Criteria:

  • Previous Biliary Tract Neoplasm surgery
  • Contraindication for MRI (such as pacemaker or inner ear implant)
  • Claustrophobia
  • Age < 16

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRCP and DWI using 3T MRI
MRCP and DWI using Magnetic resonance imaging（GE Signa,3.0 T )
Device: 3T MRI
diffusion weighted imaging(DWI) of biliary tract with GE Signa 3-tesla device
Experimental: MRCP only using 3T MRI
MRCP only using Magnetic resonance imaging（GE Signa,3.0 T )
Device: 3T MRI
diffusion weighted imaging(DWI) of biliary tract with GE Signa 3-tesla device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EHCC performance on DWI, ADC map and MRCP
Time Frame: at the end of the study
Two experienced professors of radiology observed and analyzed the images separately. If there were discrepancies, the two professors came to an agreement by consensus.
at the end of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ADC, SNR, CNR and SIR for EHCC lesion under different b values
Time Frame: at the end of the study
The ADC value of EHCC in DWI under various b values was measured, and the SNR, the CNR and the SIR in DWI were calculated. The formula for calculating the ADC value was: ADC = [ln (S1 /S2)]/ (b2 -b1) , (S and b represent signal intensity and b value, 1 and 2 represent low and high, respectively).
at the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University, China

Collaborators

First Hospital of China Medical University

Investigators

  • Principal Investigator: Xiaoping yang, MD, First Affiliated Hospital of China Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

May 8, 2012

First Posted (Estimate)

May 9, 2012

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 14, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYang

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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