Role of Perfluorobutane in Lesion Detection, Targeting and Response Assessment for Ablation of HCC

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Criteria

Inclusion Criteria:

1. Adult s (18 80 years) with HCC and who refused surgical resection

2. Tumour number not more than five and the largest tumour size not larger than 5.0 cm;

3. Ill defined lesions which are not easily detected on grey scale USG for lesion targeting.

4. Liver function status at Child Pugh class A or B;

5. East Coast Oncology Group (ECOG) performance status value 0 or 1;

6. No severe coagulopathy (e.g. platelets ≥50,000/ prothrombin time ratio ≥ 50%).

7. Available medical records and/or imaging studies.

Exclusion Criteria:

1. Presence of vascular invasion and extrahepatic metastases at pre procedure imaging study;

2. Ongoing anticoagulant treatment that cannot be stopped;

3. Combined TACE and ablation for a larger lesion