PET/CTNCT06960031
Added Value of PET/CT in Assessment of Hepatocellular Malignancy Post Radiofrequency Ablation
An observational study of PET/CT and Hepatocellular Malignancy, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to assess the residual tumoral activity versus the well ablation of اepatocellular carcinoma (HCC) post radiofrequency ablation. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- PET/CT, Hepatocellular Malignancy, Radiofrequency Ablation
- What is being tested?
- PET/CT technique
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2024to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age from 40 to 75 years.
- Both sexes.
- Patients with hepatocellular carcinoma (HCC) and underwent radiofrequency ablation (RFA) .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the residual tumoral activity versus the well ablation of اepatocellular carcinoma (HCC) post radiofrequency ablation.
Read the 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.
- Conditions
- PET/CT, Hepatocellular Malignancy, Radiofrequency Ablation
- Being tested
- PET/CT technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT techniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PET/CT technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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)
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.
Measured: From 1 month to 3 months post radiofrequency ablation
Serum Alpha-Fetoprotein (AFP) level
Serum Alpha-Fetoprotein (AFP) level will be recorded
Measured: From 1 month to 3 months post radiofrequency ablation
Mean diameter of ablated area and the mean of Liver standardized uptake value (SUvmax) .
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.
Measured: From 1 month to 3 months post radiofrequency ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start30 Dec 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PET/CTStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Samy Fahmy Abou Taira, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960031
- Sponsor's protocol ID
- 36264PR1162/3/25
- Status last verified
- May 2025
- First submitted
- 28 Apr 2025
- Last updated
- 20 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value of PET/CT in Assessment of Hepatocellular Malignancy Post Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT06960031
- Acronym / sponsor ID
- 36264PR1162/3/25
- Conditions
- PET/CT, Hepatocellular Malignancy, Radiofrequency Ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT | – | Other: PET/CT techniqueHybrid 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age from 40 to 75 years.
- Both sexes.
- Patients with hepatocellular carcinoma (HCC) and underwent radiofrequency ablation (RFA) .
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CT techniqueHybrid 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 |
Primary outcome
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.
3 secondary outcomes
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
Serum Alpha-Fetoprotein (AFP) level
Time frame: From 1 month to 3 months post radiofrequency ablation
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PET/CT and Hepatocellular Malignancy, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.