Clinical trial · Observational
Multi-Detector CT Angiography With 3D Reconstruction Versus Digital Subtraction Angiography
Interobserver Agreement of Determination of Hepatocellular Carcinoma Feeding Vessels : Multi-Detector CT Angiography With 3D Reconstruction Versus Digital Subtraction Angiography
NCT05304572CI-TRIAL-00067147completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-Detector CT angiography | Diagnostic Test | — | UNRESOLVED |
| Trans-arterial chemoembolization and DSA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- feeding vessels detectability
- timeFrame
- Baseline
- description
- 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)
- measure
- inter-observer agreement
- timeFrame
- Baseline
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (12)
- BACKGROUNDForner A, Reig M, Bruix J. Hepatocellular carcinoma. Lancet. 2018 Mar 31;391(10127):1301-1314. doi: 10.1016/S0140-6736(18)30010-2. Epub 2018 Jan 5. PMID 29307467
- BACKGROUNDBrown DB, Geschwind JF, Soulen MC, Millward SF, Sacks D. Society of Interventional Radiology position statement on chemoembolization of hepatic malignancies. J Vasc Interv Radiol. 2009 Jul;20(7 Suppl):S317-23. doi: 10.1016/j.jvir.2009.04.015. No abstract available. PMID 19560017
- BACKGROUNDMarelli L, Stigliano R, Triantos C, Senzolo M, Cholongitas E, Davies N, Tibballs J, Meyer T, Patch DW, Burroughs AK. Transarterial therapy for hepatocellular carcinoma: which technique is more effective? A systematic review of cohort and randomized studies. Cardiovasc Intervent Radiol. 2007 Jan-Feb;30(1):6-25. doi: 10.1007/s00270-006-0062-3. PMID 17103105
- BACKGROUNDLiapi E, Hong K, Georgiades CS, Geschwind JF. Three-dimensional rotational angiography: introduction of an adjunctive tool for successful transarterial chemoembolization. J Vasc Interv Radiol. 2005 Sep;16(9):1241-5. doi: 10.1097/01.RVI.0000174283.03032.8E. PMID 16151066
- BACKGROUNDKakeda S, Korogi Y, Ohnari N, Moriya J, Oda N, Nishino K, Miyamoto W. Usefulness of cone-beam volume CT with flat panel detectors in conjunction with catheter angiography for transcatheter arterial embolization. J Vasc Interv Radiol. 2007 Dec;18(12):1508-16. doi: 10.1016/j.jvir.2007.08.003. PMID 18057285
- BACKGROUNDMiyayama S, Yamashiro M, Okuda M, Yoshie Y, Sugimori N, Igarashi S, Nakashima Y, Matsui O. Usefulness of cone-beam computed tomography during ultraselective transcatheter arterial chemoembolization for small hepatocellular carcinomas that cannot be demonstrated on angiography. Cardiovasc Intervent Radiol. 2009 Mar;32(2):255-64. doi: 10.1007/s00270-008-9468-4. Epub 2008 Dec 9. PMID 19067043
- Chiaradia M, Izamis ML, Radaelli A, Prevoo W, Maleux G, Schlachter T, Mayer J, Luciani A, Kobeiter H, Tacher V. Sensitivity and Reproducibility of Automated Feeding Artery Detection Software during Transarterial Chemoembolization of Hepatocellular Carcinoma. J Vasc Interv Radiol. 2018 Mar;29(3):425-431. doi: 10.1016/j.jvir.2017.10.025. Epub 2018 Feb 3.