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

June 12, 2023 updated by: Ramy Mohammed Ahmed, Assiut University

Interobserver Agreement of Determination of Hepatocellular Carcinoma Feeding Vessels : 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut Universtiy Hospital; Alrajhy Liver institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Ramy M Ahmed, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

February 4, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDCT angiography HCC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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