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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06960031
Enrollment
70
Registered
2025-05-07
Start date
2024-12-30
Completion date
2025-04-30
Last updated
2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Malignancy, PET/CT, Radiofrequency Ablation

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.

Interventions

OTHERPET/CT technique

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.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 ablationSensitivity of fluoro-2- deoxy-D-glucose (FDG) Positron emission tomography (PET) /computed tomography (CT) to predict hepatocellular carcinoma (HCC) will be measured.

Secondary

MeasureTime frameDescription
The value of fluoro-2- deoxy-D-glucose (FDG) Positron emission tomography (PET) /computed tomography (CT)From 1 month to 3 months post radiofrequency ablationThe 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.
Serum Alpha-Fetoprotein (AFP) levelFrom 1 month to 3 months post radiofrequency ablationSerum Alpha-Fetoprotein (AFP) level 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 ablationSemi-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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026