The Diagnosis of Biliary Tract Neoplasm by Diffusion Weighted Imaging and Magnetic Resonance Cholangiopancreatography
This study is currently recruiting participants.
Verified August 2012 by China Medical University, China
Sponsor:
China Medical University, China
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
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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
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:
|
Biliary Tract Neoplasms Neoplasms Digestive System Neoplasms |
Neoplasms by Site Biliary Tract Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013