Clinical trial NCT05304572: Multi-Detector CT Angiography With 3D Reconstruction Versus Digital Subtraction Angiography
Official title: Interobserver Agreement of Determination of Hepatocellular Carcinoma Feeding Vessels : Multi-Detector CT Angiography With 3D Reconstruction Versus Digital Subtraction Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Three-Dimensional CT Angiography
HCC
TACE
DSA
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 70 consecuetive patients referred for TACE after evaluation by the multidisciplinary team at our hospital according to Barcelona clinic liver cancer (BCLC) classification and recommended treatment options.

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.

Eligibility criteria: 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

Primary outcomes:
measure: feeding vessels detectability
timeFrame: Baseline
Secondary outcomes:
measure: inter-observer agreement
timeFrame: Baseline
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Universtiy Hospital; Alrajhy Liver institute
Study officials:
affiliation: Assiut University
name: Ramy M Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
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