Clinical trial NCT06960031: Added Value of PET/CT in Assessment of Hepatocellular Malignancy Post Radiofrequency Ablation
Official title: Added Value of PET/CT in Assessment of Hepatocellular Malignancy Post Radiofrequency Ablation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PET/CT
Hepatocellular Malignancy
Radiofrequency Ablation
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This prospective cohort study will be carried out on 70 patients with hepatocellular malignancy at Tanta University Hospitals for a period from April 2025 to September 2025 after approval from institutional ethical committee.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity of fluoro-2- deoxy-D-glucose (FDG) Positron emission tomography (PET) /computed tomography (CT) to predict hepatocellular carcinoma (HCC)
timeFrame: From 1 month to 3 months post radiofrequency ablation
Secondary outcomes:
measure: The value of fluoro-2- deoxy-D-glucose (FDG) Positron emission tomography (PET) /computed tomography (CT)
timeFrame: From 1 month to 3 months post radiofrequency ablation
measure: Serum Alpha-Fetoprotein (AFP) level
timeFrame: From 1 month to 3 months post radiofrequency ablation
measure: Mean diameter of ablated area and the mean of Liver standardized uptake value (SUvmax) .
timeFrame: From 1 month to 3 months post radiofrequency ablation
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: