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

NCT06960031 | Completed

• 1 other identifier: 36264PR1162/3/25
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PET/CT; Hepatocellular Malignancy; Radiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

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

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

  From 1 month to 3 months post radiofrequency ablation

Secondary Outcomes (3)

• 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

• Serum Alpha-Fetoprotein (AFP) level

  From 1 month to 3 months post radiofrequency ablation

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

  From 1 month to 3 months post radiofrequency ablation

Study Arms (1)

PET/CT

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.

Other: PET/CT technique

Interventions

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.

PET/CT

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Diagnostic Radiology and Medical Imaging, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 7, 2025
• Study Start: December 30, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)