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MRCP Diagnoses EHCC Better When Combined DWI

This study has been completed.
Sponsor:
Collaborator:
First Hospital of China Medical University
Information provided by (Responsible Party):
Xiaoping Yang, China Medical University, China
ClinicalTrials.gov Identifier:
NCT01595217
First received: May 8, 2012
Last updated: May 14, 2017
Last verified: May 2017
  Purpose
Researching the diagnostic significance of Biliary Tract Neoplasm under combining DWI sequence with MRCP versus MRCP only separately.

Condition Intervention
Biliary Tract Neoplasm Cholangiocarcinoma Device: 3T MRI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Masking Description:
Two experienced professors of radiology observed and analyzed the images separately. They were not involved in image acquisition and were blinded to the patients' clinical, surgical and histological information. Conventional MR sequences were qualitatively analyzed in the first reading session, including T2WI, FIESTA, 2D MRCP and 3D MRCP sequences, and after one week, DWI under three different b values with ADC map combined with the preceding conventional sequences were analyzed respectively as the second reading session.
Primary Purpose: Diagnostic
Official Title: The Incremental Value of 3T Diffusion-Weighted MRI in Diagnosing Extrahepatic Cholangiocarcinoma

Resource links provided by NLM:


Further study details as provided by Xiaoping Yang, China Medical University, China:

Primary Outcome 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 Outcome 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).


Enrollment: 99
Actual Study Start Date: March 2012
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595217

Locations
China, Liaoning
Room of 3.0TMR in the FAH of CMU
Shenyang, Liaoning, China, 110001
Sponsors and Collaborators
China Medical University, China
First Hospital of China Medical University
Investigators
Principal Investigator: Xiaoping yang, MD First affiliated Hospital of China medical university
  More Information

Responsible Party: Xiaoping Yang, Principal Investigator, China Medical University, China
ClinicalTrials.gov Identifier: NCT01595217     History of Changes
Other Study ID Numbers: XYang
Study First Received: May 8, 2012
Last Updated: May 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Xiaoping Yang, China Medical University, China:
Biliary Tract Neoplasm
Cholangiocarcinoma
Diffusion magnetic resonance imaging
Magnetic resonance imaging
Magnetic resonance Cholangiopancreatography

Additional relevant MeSH terms:
Cholangiocarcinoma
Biliary Tract Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 19, 2017