Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05068076 |
Other study ID # |
ILBS-HCC-04 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 1, 2021 |
Est. completion date |
December 16, 2021 |
Study information
Verified date |
September 2021 |
Source |
Institute of Liver and Biliary Sciences, India |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Primary liver cancers are the sixth most common malignancies worldwide, with hepatocellular
carcinoma (HCC) accounting for approximately 80% of them. The Barcelona Clinic Liver Cancer
(BCLC) classification is widely used in the management of HCC. At the time of diagnosis,
fewer than 30% of the patients qualify for resection or transplant due to the large size or
multiplicity of the lesions, background chronic liver disease, and other comorbidities.
However, the recent spread of surveillance has led to early detection of hepatocellular
carcinoma (HCC), and the chance of receiving local treatment has increased. There are several
options to treat small HCCs, including surgical resection, chemical ablation,
transplantation, and percutaneous ablation (RFA/MWA).
Today, percutaneous ablation plays a key role in the treatment of early-stage HCC because it
is less invasive than surgical resection and has a good efficacy. However, targeting of
lesions under USG alone may be misleading as there may be an enhancing component which is not
seen on plain ultrasound. To overcome this problem contrast enhanced ultrasound may be used
intra-procedurally, however conventional ultrasound contrast agents show washout by 5 minutes
from the system.
In this study, the investigators prospectively analyze patients undergoing ablation with the
help of precise needle placement using a Kupffer phase ultrasound contrast agent
(perfluorobutane) and their post procedure response assessment.
Description:
International status:
Hepatocellular carcinoma (HCC) is the most common primary malignancy of the liver with
increasing incidence due to hepatitis B and C viruses . Ultrasound (USG) with, or without
alpha feto-protein levels is a standard tool for surveillance of HCC. However, it leads to
suboptimal detection rate and false referrals in the US . Use of an ultrasound contrast agent
can be helpful in surveillance and diagnosis of focal liver lesions . Second generation
ultrasound contrast agents like sulfur hexafluoride (SonoVue), perflutren lipid (Definity)
and perfluorobutane (Sonazoid) are microbubbles composed of a phospholipid shell encompassing
a low-solubility gas . The characteristic property of Sonazoid is its ability to accumulate
in the reticuloendothelial system (such as the Kupffer cells in the liver) for a sustained
period of time (up to 60 mins), which is not seen with other second generation contrast
agents . Malignant liver lesions do not contain Kupffer cells so these lesions appear
hypoechoic in the Kupffer phase (10-60 minutes) .
CEUS has been previously used for targeting of lesions for radiofrequency ablation, however
the contrast agent used in the study was Definity . CEUS with Sonazoid has been frequently
used in Japan, South Korea and Norway for diagnosis and surveillance. Diagnosis with Sonazoid
involves the vascular phase (10 sec to 5 minutes) and the Kupffer phase (10-60 minutes). The
vascular phase shows the tumor vascularity and the Kupffer phase shows the absence of
reticuloendothelial cells in the lesion (2-4). In case of a new lesion detected in the
Kupffer phase or a doubt regarding a previously detected lesion, defect reperfusion imaging
can be done for confirmation and diagnosis . In a comparison between SonoVue and Sonazoid in
diagnosis of liver lesions, Sonazoid was not inferior to SonoVue in diagnosis and
significantly better in detecting lesions during whole liver scanning .
A study was done using Sonazoid enhanced ultrasound for targeting lesions not detected by
conventional USG for ablation therapy, and it was found that CEUS detected 97% of the viable
tumours compared to 83% by conventional USG. Furthermore, 93% of the lesions which were not
detected on conventional USG were treated successfully using late phase of the contrast agent
as a guiding tool . However, CEUS using Sonazoid was not used to assess treatment response in
this study. A meta-analysis assessing the treatment response after radiofrequency ablation of
HCC using CEUS concluded that technical success was higher with Sonazoid compared to other
agents .
National status: A study evaluated the role of CEUS in guiding RFA of HCC, however the
contrast used was SonoVue and no comparison was made of the post op CEUS with routine 1 month
imaging .
The purpose of this study is to evaluate role of perfluorobutane in guiding ablation
(RFA/MWA) of HCC and to compare treatment response two hours post procedure using the same
ultrasound contrast agent with routine follow up CT/MRI at 1 month post procedure.
- Why this study- Sonazoid is available in only limited countries as of now (Japan, South
Korea, Norway)
- So only limited efficacy studies have been done and none in India.
- Also, no study as yet has simultaneously evaluated role of Sonazoid in both lesion
targeting as well as response assessment.
- Hypothesis- Immediate post-procedure CEUS with Sonazoid is not inferior to routine
contrast CT/MRI at 1 month follow-up for response assessment.