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Completed

NCT Number: NCT06960031

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

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

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PET/CT technique

Other

Hybrid positron emission tomography (PET) and computed tomography (CT) images will be performed using Philips hybrid system equipped with a 16 MDCT scanner.

The whole-body PET images from the skull vault down to the knee will be performed using several bed positions acquisition, each bed is approximately 15cm axial filed with 4mm special resolution. The time of acquisition of the emission scan is about 2 min for each bed, with a total time range between 12 and 17 min.

Primary outcomes

  1. Sensitivity of fluoro-2- deoxy-D-glucose (FDG) Positron emission tomography (PET) /computed tomography (CT) to predict hepatocellular carcinoma (HCC)

    Time frame: 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 outcomes

  1. The value of fluoro-2- deoxy-D-glucose (FDG) Positron emission tomography (PET) /computed tomography (CT)

    Time frame: 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.

  2. Serum Alpha-Fetoprotein (AFP) level

    Time frame: From 1 month to 3 months post radiofrequency ablation

    Serum Alpha-Fetoprotein (AFP) level will be recorded

  3. Mean diameter of ablated area and the mean of Liver standardized uptake value (SUvmax) .

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 7, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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