MRCP Diagnoses EHCC Better When Combined DWI

NCT01595217 | Completed DMC FDA Device

• 1 other identifier: XYang
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Biliary Tract Neoplasm; Cholangiocarcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  at the end of the study

Study Arms (2)

MRCP and DWI using 3T MRI

EXPERIMENTAL

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

Device: 3T MRI

MRCP only using 3T MRI

EXPERIMENTAL

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

Device: 3T MRI

Interventions

3T MRI DEVICE

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

MRCP and DWI using 3T MRI; MRCP only using 3T MRI

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous Biliary Tract Neoplasm surgery
• Contraindication for MRI (such as pacemaker or inner ear implant)
• Claustrophobia
• Age \< 16

Sponsors & Collaborators

• China Medical University, China: lead
• First Hospital of China Medical University: collaborator

Study Sites (1)

Room of 3.0TMR in the FAH of CMU

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Xiaoping yang, MD

  First Affiliated Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 9, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)