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Completed

NCT Number: NCT05304572

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut Universtiy Hospital; Alrajhy Liver institute

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-Detector CT angiography

Diagnostic Test

Multiphasic CT within 4 weeks interval prior to TACE will be done including non-enhanced, arterial, portal and venous phases using IV bolus injection of a 75-100-mLiodinated contrast material iopamidol at a rate of 3.0 mL/s. The images of arterial phase will be transferred to workstation to produce 3D angiographic reconstruction images .

Trans-arterial chemoembolization and DSA

Procedure

Percutaneous arterial access is achieved through the common femoral artery (19 G needle) under local anesthesia with placement of a 5-Fr sheath. A 5-Fr Cobra (C2) or sidewinder (SIM1) catheter was used for catheterizing the coeliac trunk and SMA. Then celiac and superior mesenteric angiography was done by injecting 24 mL of iopamidol using forced manual injection method or using a pump at a rate of 6 mL/s according to the operator preferences.Then a microcatheter was used for selective and super-selective access of the hepatic arteries. The micro-catheter was placed in the feeding artery as close as possible to the tumor.The chemotherapeutic drugs (Doxorubicin 50 mg) solved within 5 ml of iodinated non-ionic contrast media and then mixed with 10 ml of iodized oil (lipiodol) will be delivered through the feeding hepatic artery and then embolized using Poly-vinyl Alcohol (PVA) particles.

Primary outcomes

  1. feeding vessels detectability

    Time frame: 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 outcomes

  1. inter-observer agreement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Interobserver Agreement of Determination of Hepatocellular Carcinoma Feeding Vessels : Multi-Detector CT Angiography With 3D Reconstruction Versus Digital Subtraction Angiography

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2022
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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