Added Value of PET/CT in Assessment of Hepatocellular Malignancy Post Radiofrequency Ablation

Completed

• Conditions: PET/CT; Hepatocellular Malignancy; Radiofrequency Ablation

• Registration Number: NCT06960031
• Lead Sponsor: Tanta University

Brief Summary

This study aims to assess the residual tumoral activity versus the well ablation of اepatocellular carcinoma (HCC) post radiofrequency ablation.

Detailed Description

Hepatocellular carcinoma (HCC) is the most common primary liver malignancy and is a leading cause of cancer-related death worldwide. It is the third most common cause of death of cancer worldwide, also the sixth and fourth common cancer in worldwide and Egypt, respectively.

Radiofrequency ablation (RFA) is a technique that is recently developed for the ablation of liver tumours. It converts radio frequency waves into thermal energy, causing coagulation necrosis of the tumours. It has attracted great interest in recent years because of the excellent response rate with little morbidity. Compared with other local ablative modalities, RFA has been shown to be safer and more effective.

Positron emission tomography (PET) with 18F-fluoro-2- deoxy-D-glucose (18F-FDG) is a functional imaging tool that provides metabolic information of the lesion. It is effective for diagnosis, monitoring therapy and detection of recurrent tumours of various cancers because of its high sensitivity and specificity. However, it is less successful in the detection of primary HCC because of variable uptake. Even though the value of 18F-FDG PET for the detection of primary HCC remains controversial, 18F-FDG PET would seem to be appropriate for the follow-up of liver tumours.

Study Timeline

• Study Start: 2024-12-30
• Study First Submitted: 2025-04-28
• Study First Submitted QC: 2025-04-28
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30
• Status Verified: 2025-05
• Study First Posted: 2025-05-07
• Last Update Submitted: 2025-05-18
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Age from 40 to 75 years.
• Both sexes.
• Patients with hepatocellular carcinoma (HCC) and underwent radiofrequency ablation (RFA) .

Exclusion Criteria

• Patients with past history of contrast allergy.
• Patients with blood glucose level >200 mg/dl at the time of the study.
• High serum creatinine> 2 mg / dl.
• Small lesions < 10 mm.
• Well differentiated hepatocellular carcinoma (HCC) lesions by pathology.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of fluoro-2- deoxy-D-glucose (FDG) Positron emission tomography (PET) /computed tomography (CT) to predict hepatocellular carcinoma (HCC)	From 1 month to 3 months post radiofrequency ablation	Sensitivity of fluoro-2- deoxy-D-glucose (FDG) Positron emission tomography (PET) /computed tomography (CT) to predict hepatocellular carcinoma (HCC) will be measured.

Secondary Outcome Measures

Name	Time	Method
The value of fluoro-2- deoxy-D-glucose (FDG) Positron emission tomography (PET) /computed tomography (CT)	From 1 month to 3 months post radiofrequency ablation	The value of fluoro-2- deoxy-D-glucose (FDG) Positron emission tomography (PET) /computed tomography (CT)T in post radiofrequency ablation (RFA) follow up (Specificity, PPV, NPV, Accuracy) will be recorded.
Mean diameter of ablated area and the mean of Liver standardized uptake value (SUvmax) .	From 1 month to 3 months post radiofrequency ablation	Semi-quantitative evaluation: is including the SUvmax (standardized uptake value) and the ratio of tumour SUvmax to normal liver SUv mean (TSUvmax/LSUvmean) will be evaluated by drawing region of interest (ROI) encircling the tumour and drawing ROI for normal liver uptake.
Serum Alpha-Fetoprotein (AFP) level	From 1 month to 3 months post radiofrequency ablation	Serum Alpha-Fetoprotein (AFP) level will be recorded

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt