Multi-Detector CT Angiography With 3D Reconstruction Versus Digital Subtraction Angiography

Completed

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT05304572
• Lead Sponsor: Assiut University

Brief Summary

This study aims to investigate the feasibility and accuracy of Multi-Detector CT angiography acquired before Trans-arterial Chemo-embolization (TACE) in detecting Hepato-cellular carcinoma feeding vessels compared to DSA angiography acquired during TACE.

Detailed Description

Hepatocellular carcinoma (HCC) represents the sixth most common cancer worldwide. Trans-arterial chemoembolization (TACE) is a palliative treatment for patients with HCC who are not candidates for transplantation, surgical resection, or loco-regional ablation. This minimally invasive procedure allows delivery of a high concentration of particles and/or chemotherapeutic agents into the liver, causing ischemic cell death and permitting local delivery of high concentrations of chemotherapeutic drug. Selective administration of chemo-embolic material to the tumor is desired, where possible, to increase the effectiveness of treatment to the tumor and minimize injury to surrounding liver tissue.

Tumor detection and assessment of the tumor-feeding vessel(s) are important for an effective treatment, while limiting non-target embolization. Usually, selection of the tumor-feeding vessels during TACE has been guided by 2D digital subtraction angiography (DSA). However; this method has a disadvantage of occasional misinterpretation of tumor-feeding vessels due to superimposition of vessels. To prevent such misinterpretation, multiple selective injections and oblique projections are performed during TACE with consequent increase in procedure time, volume of injected contrast material, and radiation doses.

A relatively new approach using three-dimensional (3D) cone-beam CT angiography during TACE is reported to be extremely helpful, especially in cases of complex hepatic arterial anatomy. However, the time required for processing and evaluating this 3D angiography images may discourage its routine use by intervention radiologists because it requires either a sterile remote control for in-room review or the operator exit from the angiographic room to access a workstation. A new automatic specifically designed softwares has been developed for detection of feeding vessels after Cone beam CT, but these softwares are not widely available.

Multiphasic contrast enhanced CT is one of the recommended imaging tools for diagnosis of HCC and is routinely done before TACE. There are few reports on the application of Multi-Detector CT angiography for detection of HCC feeding vessels before TACE.

This study aims to investigate the feasibility and accuracy of Multi-Detector CT angiography for assessment of tumor-feeding vessel in patients planned for TACE compared to DSA angiography acquired during TACE.

Study Timeline

• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-03-28
• Study First Posted: 2022-03-31
• Study Start: 2022-05-01
• Primary Completion: 2023-05-01
• Status Verified: 2023-06
• Study Completion: 2023-06-01
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients with HCC not suitable for resection, liver transplantation, or percutaneous ablation.
• CHILD class A/B cirrhosis.
• patent main portal vein.
• less than 50% involvement of the liver by the tumor.
• no vascular invasion or extrahepatic spread of the HCC.
• normal renal functions.
• bilirubin level < 2 mg/dl .

Exclusion Criteria

• Pre-TACE Multi-Detector CT raw DICOM images could not be obtained for 3D processing
• patients with only available Pre-TACE MRI images
• Failed TACE due to technical factors
• Non-selective TACE technique

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
feeding vessels detectability	Baseline	The observers will evaluate DSA images of the celiac, superior mesenteric artery (SMA), common hepatic artery (CHA), right or left hepatic arteries obtained during TACE and record possible feeding arteries. Observers will be blind to additional angio-grams obtained during TACE i.e selective DSA images of the segmental arteries and feeding arteries. observers will then evaluate the CT 3D images and record possible feeding arteries. The ''ground truth'' (GT) will be the gold standard tool and is obtained after completing the above mentioned analyses by allowing the observers to evaluate by consensus pre-embolization CT 2D and 3D images, all acquired DSA images during TACE , and post-lipiodol injection CT images if available. GT was used to define true-positive, false-positive, false-negative and true negative feeding vessels.

Secondary Outcome Measures

Name	Time	Method
inter-observer agreement	Baseline	Interobserver variability was assessed using kappa statistics. Interobserver agreement was defined as excellent, fair to good, and poor by kappa values of \>0.75, 0.40-0.75, and \<0.40, respectively. for each technique.

Trial Locations

Locations (1)

Assiut Universtiy Hospital; Alrajhy Liver institute; 🇪🇬 Assiut, Egypt