Substudy: Interconnection of Arterial Tumor Feeders Through Tumor Sinusoid in HCC

NCT04641637 | Completed

• 1 other identifier: VIR-20-12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• The completeness of coverage of the tumor vasculature by therapeutic agent at the completion of the treatment as evaluated on non-contrast CT scan

  The completeness of coverage of the tumor vasculature by therapeutic agent at the completion of the treatment as evaluated on non-contrast CT scan

  immediately after completion of procedure

Secondary Outcomes (1)

• Tumor response

  3 months

Study Arms (1)

Selective catheterization of segmental or more peripheral arteries in TACE

OTHER

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.

Procedure: TACE

Interventions

TACE PROCEDURE

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.

Selective catheterization of segmental or more peripheral arteries in TACE

Eligibility Criteria

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• Simon Yu, Professor

  DIIR, CUHK, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 24, 2020
• Study Start: June 30, 2022
• Primary Completion: February 28, 2023
• Study Completion: April 28, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)