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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by China Medical University, China.
Recruitment status was  Recruiting
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
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 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:
Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 30, 2014