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MRCP Diagnoses EHCC Better When Combined DWI

Primary Purpose

Biliary Tract Neoplasm, Cholangiocarcinoma

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

3T MRI

About this trial

This is an interventional diagnostic trial for Biliary Tract Neoplasm focused on measuring Biliary Tract Neoplasm, Cholangiocarcinoma, Diffusion magnetic resonance imaging, Magnetic resonance imaging, Magnetic resonance Cholangiopancreatography

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Room of 3.0TMR in the FAH of CMU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

MRCP and DWI using 3T MRI

MRCP only using 3T MRI

Arm Description

MRCP and DWI using Magnetic resonance imaging（GE Signa,3.0 T )

MRCP only using Magnetic resonance imaging（GE Signa,3.0 T )

Outcomes

Primary Outcome Measures

EHCC performance on DWI, ADC map and MRCP

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

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).

Full Information

NCT ID

NCT01595217

First Posted

May 8, 2012

Last Updated

May 14, 2017

Sponsor

China Medical University, China

Collaborators

First Hospital of China Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01595217

Brief Title

MRCP Diagnoses EHCC Better When Combined DWI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

March 2012 (Actual)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

China Medical University, China

Collaborators

First Hospital of China Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Biliary Tract Neoplasm, Cholangiocarcinoma

Keywords

Biliary Tract Neoplasm, Cholangiocarcinoma, Diffusion magnetic resonance imaging, Magnetic resonance imaging, Magnetic resonance Cholangiopancreatography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MRCP and DWI using 3T MRI

Arm Type

Experimental

Arm Description

MRCP and DWI using Magnetic resonance imaging（GE Signa,3.0 T )

Arm Title

MRCP only using 3T MRI

Arm Type

Experimental

Arm Description

MRCP only using Magnetic resonance imaging（GE Signa,3.0 T )

Intervention Type

Device

Intervention Name(s)

3T MRI

Intervention Description

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

Primary Outcome Measure Information:

Title

EHCC performance on DWI, ADC map and MRCP

Description

Two experienced professors of radiology observed and analyzed the images separately. If there were discrepancies, the two professors came to an agreement by consensus.

Time Frame

at the end of the study

Secondary Outcome Measure Information:

Title

ADC, SNR, CNR and SIR for EHCC lesion under different b values

Description

Time Frame

at the end of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaoping yang, MD

Organizational Affiliation

First Affiliated Hospital of China Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Room of 3.0TMR in the FAH of CMU

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110001

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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MRCP Diagnoses EHCC Better When Combined DWI

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