HCC - Hepatocellular CarcinomaNCT06602986
Measuring the Density of Iodine in Lipiodol Depositions: Detecting an Invisible Residual Tumor After Conventional Transarterial Chemoembolization for Hepatocellular Carcinoma
A study testing TACE in people with HCC - Hepatocellular Carcinoma, run by Pak Emirates Military Hospital at 1 site in Pakistan.
Trial summary
ABSTRACT Objective: To detect presence of a residual tumor in patients of hepatocellular carcinoma (HCC) treated with Lipiodol based conventional trans arterial chemoembolization (cTACE) using density measurements on follow-up computed tomography (CT) scans Study Design: Prospective observational interventional study… Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- What is being tested?
- TACE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Oct 2024to 13 Jul 2025
- Phase
- Interventional
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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Clinical diagnosis of HCC disease
- Must be able to swallow tablets
Who cannot join
- Insulin dependent diabetes
- Thyroid disease
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
PakEmiratesMH
Rawalpindi, Punjab Province, 55050
Dr Rabbia Fatima Professor head of Radiology department,AFIRI,PEMH, Rawalpind, MBBS,FCPS,FRCR, 03117055191, rabbiafatimasattar555@gmail.com
About this study
ABSTRACT Objective: To detect presence of a residual tumor in patients of hepatocellular carcinoma (HCC) treated with Lipiodol based conventional trans arterial chemoembolization (cTACE) using density measurements on follow-up computed tomography (CT) scans Study Design: Prospective observational interventional study Place and Duration of Study: Interventional Radiology department of Armed Forces Institute of Radiology and Imaging (AFIRI) from April 2023-March 2024 Methodology: 96 patients undergoing conventional TACE were included in the study and followed up for residual tumor or tumor free status assessment using density measurement for iodine depositions using CT scan analysis and compared with gold standard digital subtraction angiography (DSA). Primary variables measured were comparison of enhancement scores between those with a residual tumor versus tumor free as well as the volume of iodine depositions in the arterial and venous phase between both groups. Sensitivity and specificity of the CT scan in assessing tumor diagnosis was compared with the gold standard digital subtraction angiography.
- Conditions
- HCC - Hepatocellular Carcinoma
- Being tested
- TACE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEDiagnostic test
study was carried out in our setup for two major reasons. One was to decrease reliance on DSA since it is a costly investigation in our medical setups and the facility is not available except for a few centers of excellence which creates issues with treatments plan of patients admitted for treatment using TACE and subsequent follow-up visits to assess the presence or absence of HCC tumors. The mean age of patients in our treatment group was in the early sixties. This is in line with the median age of diagnosis for HCC globally as evidenced by studies done by Mc Glynn et al12 and Konyn et al13. Gender distribution was predominantly male in our study group in line with available literature14. The Child Pugh classification which quantifies severity of chronic liver disease by assessing clinical parameters was used in our study as well15. Since the inclusion criteria and procedural requirement required normal bilirubin levels, all subjects in the study protocol were in Class A16.
The prima
| Study group | Role | What they receive |
|---|---|---|
| International study | Experimental | Hepatocellular carcinoma (HCC) is associated with considerable morbidity and mortality with a high prevalence in developing countries including Pakistan1. Statistics from Pakistan indicate that the cancer is among the top five causes of cancer deaths nationally and the commonest cancer in adult males with respect to frequency of diagnosis2. Risk factors implicated in our population are chronic hepatitis B and C infection, alcohol consumption, autoimmune hepatitis, Wilson disease and alpha-1 anti-trypsin deficiency as the commonest causes3. It is projected that lifestyle modifications including eating habits and increase in the frequency of hepatitis B and C infections would increase the incidence of the disease by threefold in the next decade4.
The treatment options for the disease are diverse depending on the tumor size, location, time of diagnosis and associated co-morbidities. Small tumor with local restriction are offered surgical options including resection and/or tr Receives: Diagnostic Test: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the density of Iodine in Lipiodol depositions: Detecting an Invisible Residual Tumor after Conventional Transarterial Chemoembolization for Hepatocellular carcinoma
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start12 Oct 2024 (estimated)
- Primary completion12 Feb 2025 (estimated)
- Study completion13 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pak Emirates Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR.Talha Arshad, Pak Emirates Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602986
- Sponsor's protocol ID
- PakEmirates AFIRI
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No