Measuring the Density of Iodine in Lipiodol Depositions: Detecting an Invisible Residual Tumor After Conventional Transarterial Chemoembolization for Hepatocellular Carcinoma

Pak Emirates Military Hospital

Status: Not yet enrolling

Conditions: HCC - Hepatocellular Carcinoma

Treatments: Diagnostic Test: TACE

Study type: Interventional

Funder types: Other

Identifiers

NCT06602986

PakEmirates AFIRI

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 16 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of HCC disease
• Must be able to swallow tablets

Exclusion criteria

• Insulin dependent diabetes
• Thyroid disease

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

96 participants in 1 patient group

International study

Experimental group

Description:

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

Treatment:

Diagnostic Test: TACE