- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04641637
Substudy: Interconnection of Arterial Tumor Feeders Through Tumor Sinusoid in HCC
April 28, 2023 updated by: Simon Yu, Chinese University of Hong Kong
Substudy of Protocol TACE Emulsion Versus Suspension (NCT03268499): Interconnection of Arterial Tumor Feeders Through Tumor Sinusoid in Hepatocellular Carcinoma(HCC): In-vivo Proof of Concept and Clinical Implication
It is postulated that all arterial tumor feeders supplying a HCC tumor are interconnected with each other through the tumor sinusoid, such that when one of the feeders is catheterized for delivery of a liquid embolic agent, the whole tumor sinusoid will be embolized, if the arterial blood flow in all the other feeders are stopped temporarily to create a negative pressure gradient.
Study Overview
Detailed Description
Selective catheterization of segmental or more peripheral arteries in the procedure of transarterial treatment could be crucial in making a significant difference in survival outcome (1).
Subsegmental chemoembolization (TACE) leading to portal vein visualization is associated with a higher chance of complete response (2), and complete response is a robust predictor of better overall survival (3).
Selective TACE might also help to preserve liver function because TACE damages liver parenchyma and repeated TACE could lead to deterioration in liver function (4).
In a procedure of ultra-selective TACE, each of the arterial tumor feeders is supposed to be catheterized for complete treatment of the whole tumor when there are multiple tumor feeders (5), it could be time consuming and technically challenging to achieve catheterize all the tumor feeders at a sub-subsegmental level when difficult arterial anatomy is encountered, even with the guidance of a automated tumor-feeders detection software (6).
In the angioarchitecture of HCC, arterial tumor feeders lead to tumor sinusoid which is an interconnected network of vascular channel within the tumor substance (7).
It is postulated that all arterial tumor feeders supplying a HCC tumor are interconnected with each other through the tumor sinusoid, such that when one of the feeders is catheterized for delivery of a liquid embolic agent, the whole tumor sinusoid will be embolized, if the arterial blood flow in all the other feeders are stopped temporarily to create a negative pressure gradient.
Study Type
Interventional
Enrollment (Actual)
40
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: Carmen Wong
- Phone Number: (852) 35053210
- Email: carmenwongsp@cuhk.edu.hk
Study Contact Backup
- Name: Pui Man Chong
- Phone Number: (852) 35054094
- Email: siuman@cuhk.edu.hk
Study Locations
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Hong Kong, Hong Kong
- Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
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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
Description
Inclusion criteria Child-Pugh grade A, HCC diagnosed with typical arterial enhancement and portal washout patterns on contrast enhanced CT or MRI, solitary tumor, hypervascularity, well-defined margin, size ≤7cm, at least two arterial tumor feeders on CT scan
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Selective catheterization of segmental or more peripheral arteries in TACE
From the digital subtraction angiography (DSA), the number of arterial tumor feeders to the HCC is identified.
One or more feeder(s) is to be catheterized for delivery of therapeutic agent using a 2.4 French microcatheter (Merit Maestro, Merit Medical Systems, Utah, USA), and the other feeder(s) is occluded with a balloon catheter using 0.1 to 0.2mL diluted contrast for inflation (4mm x 10mm Temporary Occlusion Balloon Catheter, Occlusafe, Terumo Clinial Supply, Gifu, Japan).
The occlusion target could be a feeder or a common trunk leading to a number of feeders.
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Through a 7 French sheath placed through a single femoral arterial puncture, a guide catheter (Cobra 1 Guide Catheter, Mach 1, Boston Scientific Corporation, Marlborough, USA) is placed at the coeliac axis.
From the digital subtraction angiography (DSA), the number of arterial tumor feeders to the HCC is identified.
One or more feeder(s) is to be catheterized for delivery of therapeutic agent using a 2.4 French microcatheter (Merit Maestro, Merit Medical Systems, Utah, USA), and the other feeder(s) is occluded with a balloon catheter using 0.1 to 0.2mL diluted contrast for inflation (4mm x 10mm Temporary Occlusion Balloon Catheter, Occlusafe, Terumo Clinial Supply, Gifu, Japan).
The occlusion target could be a feeder or a common trunk leading to a number of feeders.
The therapeutic agent was delivered under fluoroscopic control until the vasculature of the whole tumors is entirely filled, which was assessed with DSA and non-contrast CT performed at the completion of the procedure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The completeness of coverage of the tumor vasculature by therapeutic agent at the completion of the treatment as evaluated on non-contrast CT scan
Time Frame: immediately after completion of procedure
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The completeness of coverage of the tumor vasculature by therapeutic agent at the completion of the treatment as evaluated on non-contrast CT scan
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immediately after completion of procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor response
Time Frame: 3 months
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Tumor response as evaluated on CT scan
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Simon Yu, Professor, DIIR, CUHK, Hong Kong
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)
June 30, 2022
Primary Completion (Actual)
February 28, 2023
Study Completion (Actual)
April 28, 2023
Study Registration Dates
First Submitted
November 18, 2020
First Submitted That Met QC Criteria
November 18, 2020
First Posted (Actual)
November 24, 2020
Study Record Updates
Last Update Posted (Actual)
May 1, 2023
Last Update Submitted That Met QC Criteria
April 28, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VIR-20-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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