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

NCT05068076 | Completed

• 1 other identifier: ILBS-HCC-04
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma; Microwave Ablation

Outcome Measures

Primary Outcomes (1)

• Comparison of treatment response two hours post procedure with Perfluorobutane with routine CECT/CEMRI done at 1 month post procedure using modified RECIST criteria for HCC.

  Post procedure CEUS will be done which will be compared with 1 month CECT/CEMRI to compare treatment response of ablation

  upto 6 months

Secondary Outcomes (1)

• Targeting of lesions (fulfilling CEUS LIRADS 4/5 criteria) in the Kupffer phase for ablation

  upto 6 months

Study Arms (1)

Patients undergoing ablation for HCC

EXPERIMENTAL

Pre-procedure CEUS will be performed on patients undergoing ablation followed by targeting of lesions for precise needle placement in the Kupffer phase. 2 hours post procedure USG with contrast will also be done for response assessment

Drug: Perfluorobutane

Interventions

Perfluorobutane DRUG

Perfluorobutane enhanced ultrasound will be done prior to ablation of HCC and after 2hours post ablation and comparison will be done with 1 month post procedure CT/MRI

Also known as: Sonazoid

Patients undergoing ablation for HCC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult s (18 80 years) with HCC and who refused surgical resection
• Tumour number not more than five and the largest tumour size not larger than 5.0 cm;
• Ill defined lesions which are not easily detected on grey scale USG for lesion targeting.
• Liver function status at Child Pugh class A or B;
• East Coast Oncology Group (ECOG) performance status value 0 or 1;
• No severe coagulopathy (e.g. platelets ≥50,000/ prothrombin time ratio ≥ 50%).
• Available medical records and/or imaging studies.

You may not qualify if:

• Presence of vascular invasion and extrahepatic metastases at pre procedure imaging study;
• Ongoing anticoagulant treatment that cannot be stopped;
• Combined TACE and ablation for a larger lesion

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Related Publications (1)

• Mukund A, Bansal A, Patidar Y, Thapar S, Sharma MK, Sarin SK. Role of contrast-enhanced ultrasound with Perfluorobutane in lesion detection, guidance for microwave ablation, and response assessment of hepatocellular carcinoma. Abdom Radiol (NY). 2022 Oct;47(10):3459-3467. doi: 10.1007/s00261-022-03609-y. Epub 2022 Jul 16.

  PMID: 35842563 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

perfluorobutane; Sonazoid

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

• Amar Mukund, MBBS, MD

  Institute of Liver & Biliary Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: October 5, 2021
• Study Start: October 1, 2021
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)