Biliary Tract NeoplasmNCT01595217
MRCP Diagnoses EHCC Better When Combined DWI
A study testing 3T MRI in people with Biliary Tract Neoplasm and Cholangiocarcinoma, run by China Medical University, China at 1 site in China.
Trial summary
Researching the diagnostic significance of Biliary Tract Neoplasm under combining DWI sequence with MRCP versus MRCP only separately. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Biliary Tract Neoplasm, Cholangiocarcinoma
- What is being tested?
- 3T MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous Biliary Tract Neoplasm surgery
- Contraindication for MRI (such as pacemaker or inner ear implant)
- Claustrophobia
- Age < 16
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Incremental Value of 3T Diffusion-Weighted MRI in Diagnosing Extrahepatic Cholangiocarcinoma
Researching the diagnostic significance of Biliary Tract Neoplasm under combining DWI sequence with MRCP versus MRCP only separately.
Read the 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.
- Conditions
- Biliary Tract Neoplasm, Cholangiocarcinoma
- Being tested
- 3T MRI
- Keywords
- Biliary Tract Neoplasm, Cholangiocarcinoma, Diffusion magnetic resonance imaging, Magnetic resonance imaging, Magnetic resonance Cholangiopancreatography
- Medical subject headings
- Biliary Tract Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3T MRIDevice
diffusion weighted imaging(DWI) of biliary tract with GE Signa 3-tesla device
| Study group | Role | What they receive |
|---|---|---|
| MRCP and DWI using 3T MRI | Experimental | MRCP and DWI using Magnetic resonance imaging（GE Signa,3.0 T ) Receives: Device: 3T MRI |
| MRCP only using 3T MRI | Experimental | MRCP only using Magnetic resonance imaging（GE Signa,3.0 T ) Receives: Device: 3T MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the end of the study
Secondary outcomes (1)
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).
Measured: at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospital of China Medical University
- Responsible party
- Principal investigator, Xiaoping Yang, China Medical University, China
- Investigators
- Xiaoping yang, MD, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595217
- Sponsor's protocol ID
- XYang
- Status last verified
- May 2017
- First submitted
- 8 May 2012
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incremental Value of 3T Diffusion-Weighted MRI in Diagnosing Extrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT01595217
- Acronym / sponsor ID
- XYang
- Conditions
- Biliary Tract Neoplasm, Cholangiocarcinoma
- Keywords
- Biliary Tract Neoplasm, Cholangiocarcinoma, Diffusion magnetic resonance imaging, Magnetic resonance imaging, Magnetic resonance Cholangiopancreatography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Collaborators
- First Hospital of China Medical University
- Study start
- Mar 2012 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 9 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRCP and DWI using 3T MRI | Experimental | Device: 3T MRIMRCP and DWI using Magnetic resonance imaging（GE Signa,3.0 T ) |
| MRCP only using 3T MRI | Experimental | Device: 3T MRIMRCP only using Magnetic resonance imaging（GE Signa,3.0 T ) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Previous Biliary Tract Neoplasm surgery
- Contraindication for MRI (such as pacemaker or inner ear implant)
- Claustrophobia
- Age < 16
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3T MRIdiffusion weighted imaging(DWI) of biliary tract with GE Signa 3-tesla device | Device | MRCP and DWI using 3T MRI, MRCP only using 3T MRI |
Primary outcome
EHCC performance on DWI, ADC map and MRCP
Time frame: at the end of the study
Two experienced professors of radiology observed and analyzed the images separately. If there were discrepancies, the two professors came to an agreement by consensus.
1 secondary outcome
ADC, SNR, CNR and SIR for EHCC lesion under different b values
Time frame: at the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Individual participant dataSharing planned: No
Related trials for Biliary Tract Neoplasm
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
RecruitingObservational study
Observational Study Protocol: LIVER-R
Hepatobiliary Cancers
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 3
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
Biliary Tract Cancer
Active, not recruitingPhase 2
NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer
Advanced Biliary Tract Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoping yang, MD principal investigator
First Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3T MRI in people with Biliary Tract Neoplasm and Cholangiocarcinoma, run by China Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EHCC performance on DWI, ADC map and MRCP (time frame: at the end of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.