The Diagnosis of Biliary Tract Neoplasm by Diffusion Weighted Imaging and Magnetic Resonance Cholangiopancreatography

This study is currently recruiting participants.
Verified August 2012 by China Medical University, China
Sponsor:
Information provided by (Responsible Party):
Xiaoping Yang, China Medical University, China
ClinicalTrials.gov Identifier:
NCT01595217
First received: May 8, 2012
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Biliary Tract Neoplasm
Device: 3T MRI
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Application of Combining Diffusion Weighted Imaging(DWI) and Magnetic Resonance Cholangiopancreatography(MRCP) at 3.0T MRI in the Diagnosis of Biliary Tract Neoplasm

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proportion of Biliary Tract Neoplasm diagnoses in MRCP with DWI and MRCP only groups [ Time Frame: at the end of the study (up to 1 year) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of positive biopsies in MRCP with DWI and MRCP only groups [ Time Frame: at the end of the study (up to 1 year) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (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-T 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595217

Locations
China, Liaoning
Room of 3.0TMR in the FAH of CMU Recruiting
Shenyang, Liaoning, China, 110001
Contact: Ke Ren, Professor    13940283566 ext 024-83282305    renke815@sina.com   
Sponsors and Collaborators
China Medical University, China
Investigators
Study Director: Ke Ren, Professor First affiliated Hospital of China medical university
  More Information

No publications provided

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: August 9, 2012
Health Authority: China: Ethics Committee

Keywords provided by China Medical University, China:
Biliary Tract Neoplasm
MRI
DWI
Diagnosis

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 23, 2014