Skip to main content
OpenTrials
Completed

NCT Number: NCT01595217

MRCP Diagnoses EHCC Better When Combined DWI

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Biliary Tract Neoplasm Adenocarcinoma Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Room of 3.0TMR in the FAH of CMU

Shenyang, Liaoning, 110001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3T MRI

Device

diffusion weighted imaging(DWI) of biliary tract with GE Signa 3-tesla device

Primary outcomes

  1. 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 outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Collaborators

  • First Hospital of China Medical University

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 9, 2012
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.