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A Study to Evaluate Efficacy and Safety of TheraSphere and Resection Combination Therapy in Patients With Single Large ((> 5cm, Long Diameter ) Hepatocellular Carcinoma : Exploratory Trial

NCT05038397 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-09-09

No results posted yet for this study

Summary

A study to evaluate efficacy and safety of TheraSphere and resection combination therapy in patients with single large ((\> 5cm, long diameter ) hepatocellular carcinoma :

Conditions

  • Carcinoma, Hepatocellular

Interventions

DEVICE

Theraspere

Prior to the administration of TheraSphere, the patient should undergo hepatic arterial catheterization using balloon catheterization or other appropriate angiographic techniques to prevent extrahepatic shunting. Following the placement of the hepatic catheter, 75 MBq to 150 MBq (2 mCi to 4 mCi) of Tc-99m MAA is administered into the hepatic artery to determine the extent of A-V shunting to the lungs and to confirm the absence of gastric and duodenal flow. When the possibility of extrahepatic shunting has been evaluated and the patient deemed acceptable for treatment, TheraSphere may be administered.

Sponsors & Collaborators

  • BTG International Inc.

    collaborator OTHER

  • Seoul National University Hospital

    collaborator OTHER

  • MedicalExcellence

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-30
Primary Completion
2021-06-02
Completion
2021-06-02

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05038397 on ClinicalTrials.gov