- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03811431
Contrast Enhanced Ultrasound Guidance Biopsy for the Diagnosis of Liver Tumors (ConCLUDe)
January 17, 2019 updated by: Tudor Mocan, Iuliu Hatieganu University of Medicine and Pharmacy
Real Time Contrast-enhanced Compared to Conventional Ultrasound Guided Biopsy in the Diagnosis of Hepatic Tumors on a Background of Advanced Chronic Liver Disease. A Prospective Clinical Study.
The main purpose of this study is to compare contrast-enhanced ultrasound guided liver biopsy (CEUS-LB) with conventional ultrasound guided liver biopsy (US-LB) in the diagnosis of liver tumors developed on a background of advanced chronic liver diseases.
All patients referred to our department with a CT/MRI diagnosis of hepatic neoplasia will be randomly assigned to either CEUS-LB or US-LB.
All LB will be performed by the same investigator.
For the randomisation the flip coin technique will be used.
One investigator without access to previous C/MRI/US report will do the randomization
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
A prospective parallel group clinical trial will be performed.
The study protocol was implemented in our Institute starting January 2011 ending January 1 2020.
During this period, all patients with a suspicion of primary liver neoplasia either on CT or MRI will be evaluated in different departments from our Institute for possible inclusion.
Patients with a typical aspect of benign FLLs will not be included in the study.
Patients fulfilling the following criteria: presence of cirrhosis or other chronic liver disease (according to a liver stiffness evaluated by transient elastography higher than 10 kilopascals), Child-Pugh score no higher than B7 and absence of perihepatic ascites, platelet count > 50.000 per mm3 or an international normalized ratio < 1.6; will be further on sent to the department of interventional ultrasound.
).
All patients referred to interventional department will underwent a B-mode ultrasound (1 investigator) testing the feasibility of performing liver biopsy.
At this time point the conspicuity of the tumors will be recorded into either poorly or not poorly visible.
Included patients will be randomly divided by another investigator (T.M.) without access to the previous US, CT or MRI report into two groups: a group that will underwent US guided liver biopsy (USLB) and another one who will underwent CEUS guided liver biopsy (CEUSLB).
The randomization will be made based of flip coin technique.
The side of the coin (heads-USLB, tails CEUSLB) determined the assignment of each subject.
All biopsies will be performed by the same investigator (Z.S.) with an experience of more than 8 years in ultrasound interventions.
Patients assigned to USLB or CEUSLB will be blinded.
The investigators assessing the outcomes will not be informed about the LB technique used in each patient.
The reasons for performing biopsy will be either inconclusive CT/MRI findings , or patients with a typical pattern of HCC on CT/MRI in whom a histological diagnosis is necessary in order to start systemic therapy (sorafenib).
Different from other major society's guidelines, in our country a histological diagnosis of HCC is mandatory in patients referred for sorafenib treatment.
Patients with small FLLs (BCLC 0 or A) and typical aspect of HCC on CT/MRI will be sent directly to surgery or radiofrequency ablation according to EASL guidelines.
Study Type
Interventional
Enrollment (Anticipated)
138
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tudor Mocan, MD
- Phone Number: +40 799861946
- Email: Mocac.Tudor@umfcluj.ro
Study Contact Backup
- Name: Zeno Sparchez, MD, PhD
- Phone Number: +40 0729890911
- Email: zsparchez@yahoo.co.uk
Study Locations
-
-
Please Enter The State Or Province
-
Cluj-Napoca, Please Enter The State Or Province, Romania, 400126
- Recruiting
- Regional Institute of Gastroenterology and Hepatology "Octavian Fodor"
-
Contact:
- Tudor Mocan
- Phone Number: +40 799 861946
- Email: Mocan.Tudor@umfcluj.ro
-
Contact:
- Ioana Rusu
- Email: ioana.russu@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- presence of cirrhosis or other chronic liver disease (according to a liver stiffness evaluated by transient elastography higher than 10 kilopascals)
- Child-Pugh score no higher than B7 and absence of perihepatic ascites
- platelet count > 50.000 per mm3
- international normalized ratio < 1.6
Exclusion Criteria:
- tumors located tin sonography blind areas
- refuse to sign the informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CEUS guidance
SonoVue 2, 4 ml
|
Conventional liver biopsy
Other Names:
|
Experimental: Conventional US guidance
No drugs
|
Conventional liver biopsy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients in whom contrast enhanced ultrasound guided liver biopsy leads to the final diagnosis as compared to conventional ultrasound guided liver biopsy. The final diagnosis will be assessed based on histological examination.
Time Frame: From randomisation until the first documented histological diagnosis. In cases with a negative diagnosis based on histology imaging follow-up using CT or MRI will be carried on for a period of at least 12 months.
|
In patients in whom a final histological diagnosis can not be achieved with the use of contrast enhanced or ultrasound guidance a second liver biopsy will be considered if appropriate in the next 3-4 weeks.
In cases where a second liver biopsy will be judged not to be necessary a follow-up using imaging techniques will be performed until a final diagnosis is reached.
|
From randomisation until the first documented histological diagnosis. In cases with a negative diagnosis based on histology imaging follow-up using CT or MRI will be carried on for a period of at least 12 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2011
Primary Completion (Anticipated)
January 1, 2020
Study Completion (Anticipated)
January 1, 2020
Study Registration Dates
First Submitted
January 16, 2019
First Submitted That Met QC Criteria
January 17, 2019
First Posted (Actual)
January 22, 2019
Study Record Updates
Last Update Posted (Actual)
January 22, 2019
Last Update Submitted That Met QC Criteria
January 17, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIOPTICON
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available
IPD Sharing Time Frame
Data available within 12 months of study completion
IPD Sharing Access Criteria
Data access request will be reviewed by an external Independent review panel.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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