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

NCT05304572 | Completed

• 1 other identifier: MDCT angiography HCC
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Three-Dimensional CT Angiography; HCC; TACE; DSA

Outcome Measures

Primary Outcomes (1)

• feeding vessels detectability

  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 Outcomes (1)

• inter-observer agreement

  Baseline

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 .

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Universtiy Hospital; Alrajhy Liver institute

Asyut, 71515, Egypt

Location

Related Publications (12)

• Forner 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 BACKGROUND

• Brown 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 BACKGROUND

• Marelli 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 BACKGROUND

• Liapi 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 BACKGROUND

• Kakeda 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 BACKGROUND

• Miyayama 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 BACKGROUND

• 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.

  PMID: 29402612 BACKGROUND

• Deschamps F, Solomon SB, Thornton RH, Rao P, Hakime A, Kuoch V, de Baere T. Computed analysis of three-dimensional cone-beam computed tomography angiography for determination of tumor-feeding vessels during chemoembolization of liver tumor: a pilot study. Cardiovasc Intervent Radiol. 2010 Dec;33(6):1235-42. doi: 10.1007/s00270-010-9846-6.

  PMID: 20390271 BACKGROUND

• Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, Christensen E, Pagliaro L, Colombo M, Rodes J; EASL Panel of Experts on HCC. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol. 2001 Sep;35(3):421-30. doi: 10.1016/s0168-8278(01)00130-1. No abstract available.

  PMID: 11592607 BACKGROUND

• Huang JH, Fan WJ, Li CJ, Gu YK, Zhang L, Gao F, Lu LW, Li WQ. Application of multislice spiral CT angiography on transcatheter arterial chemoembolization for hepatocellular carcinoma. Ai Zheng. 2009 Feb;28(2):159-63. Epub 2009 Feb 15.

  PMID: 19550129 BACKGROUND

• Kim I, Kim DJ, Kim KA, Yoon SW, Lee JT. Feasibility of MDCT angiography for determination of tumor-feeding vessels in chemoembolization of hepatocellular carcinoma. J Comput Assist Tomogr. 2014 Sep-Oct;38(5):742-6. doi: 10.1097/RCT.0000000000000103.

  PMID: 24834885 BACKGROUND

• Ahmed RM, Ali WA, AbdelHakam AM, Ahmed SH. Detection of hepatocellular carcinoma feeding vessels: MDCT angiography with 3D reconstruction versus digital subtraction angiography. BMC Med Imaging. 2024 Sep 18;24(1):250. doi: 10.1186/s12880-024-01408-z.

  PMID: 39294600 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• Ramy M Ahmed, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of interventional and diagnostic radiology

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: March 31, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

EG (1)