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The Application of Combining Diffusion Weighted Imaging(DWI) and Magnetic Resonance Cholangiopancreatography(MRCP) at 3.0T MRI in the Diagnosis of Biliary Tract Neoplasm


Phase 1/Phase 2
16 Years
N/A
Open (Enrolling)
Both
Biliary Tract Neoplasm

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Trial Information

The Application of Combining Diffusion Weighted Imaging(DWI) and Magnetic Resonance Cholangiopancreatography(MRCP) at 3.0T MRI in the Diagnosis of Biliary Tract Neoplasm


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Proportion of Biliary Tract Neoplasm diagnoses in MRCP with DWI and MRCP only groups

Outcome Time Frame:

at the end of the study (up to 1 year)

Safety Issue:

Yes

Principal Investigator

Ke Ren, Professor

Investigator Role:

Study Director

Investigator Affiliation:

First affiliated Hospital of China medical university

Authority:

China: Ethics Committee

Study ID:

XYang

NCT ID:

NCT01595217

Start Date:

March 2012

Completion Date:

March 2013

Related Keywords:

  • Biliary Tract Neoplasm
  • Biliary Tract Neoplasm
  • MRI
  • DWI
  • Diagnosis
  • Biliary Tract Neoplasms
  • Neoplasms

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