MRCP Diagnoses EHCC Better When Combined DWI

Overview

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

Full Title of Study: “The Incremental Value of 3T Diffusion-Weighted MRI in Diagnosing Extrahepatic Cholangiocarcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2013

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.

Interventions

  • Device: 3T MRI
    • diffusion weighted imaging(DWI) of biliary tract with GE Signa 3-tesla device

Arms, Groups and Cohorts

  • Experimental: MRCP and DWI using 3T MRI
    • MRCP and DWI using Magnetic resonance imaging(GE Signa,3.0 T )
  • Experimental: MRCP only using 3T MRI
    • MRCP only using Magnetic resonance imaging(GE Signa,3.0 T )

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • China Medical University, China
  • Collaborator
    • First Hospital of China Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xiaoping Yang, Principal Investigator – China Medical University, China
  • Overall Official(s)
    • Xiaoping yang, MD, Principal Investigator, First Affiliated Hospital of China Medical University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.