MRCP Diagnoses EHCC Better When Combined DWI

Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01595217
• Other study ID #: XYang
• Status: Completed
• Phase: N/A
• First received: May 8, 2012
• Last updated: May 14, 2017
• Start date: March 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2017
• Source: China Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Neoplasm
• Biliary Tract Neoplasms
• Cholangiocarcinoma

Intervention

Device:
• 3T MRI
diffusion weighted imaging(DWI) of biliary tract with GE Signa 3-tesla device

Locations

Country	Name	City	State
China	Room of 3.0TMR in the FAH of CMU	Shenyang	Liaoning

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University, China	First Hospital of China Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at the end of the study
Secondary	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).	at the end of the study