Clinical trial · Interventional
Study of Automatic Image Fusion of a CT Volume With Ultrasound During Percutaneous Ablation Treatment of Hepatic Tumors
Study of the Contribution of Automatic Image Fusion of a Cone-beam CT Volume With Ultrasound During Percutaneous Ablation Treatment of Hepatic Tumors
NCT04420026CI-TRIAL-00061201IATcompletedN/AClinicalTrials.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)
The automatic fusion of the ultrasound with a cone-beam CT volume will guide the positioning of the electrodes, despite the visibility of the tumor in ultrasound, in patients treated with irreversible electroporation in the interventional radiology room at Avicenna Hospital for hepatocellular carcinoma (HCC). The objective is to evaluate the primary success rate of the automatic cone-beam CT fusion procedure and ultrasound, regardless of the tumor's visibility status in ultrasound.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interact Active Tracker | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- Hepatocellular tumours
- interventionNames
- Radiation: Interact Active Tracker
Primary outcomes (1)
- measure
- Evaluation of the primary success rate of percutaneous ablation treatment with IRE of hepatic tumors, as a function of the ultrasound visibility of the tumor, when using automatic CT cone-beam fusion and ultrasound
- timeFrame
- At 1 month on post-operative imaging
- description
- Primary success is assessed on the control MRI or CT performed one month after the first IRE (Irreversible Electroporation) ablation procedure targeting a given tumor. It is defined by the absence of visible recurrence at 1 month on post-operative imaging. In the case of a partial response, a % of active tumor will be evaluated.
Secondary outcomes (10)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years * Patient treated at Avicenna Hospital for HCC by irreversible electroporation (IRE) * Patient whose tumor treatment requires the use of fusion tools with CBCT imaging at the beginning of the procedure * Patients with a scheduled follow-up examination 1 month after the ablation procedure by irreversible electroporation (IRE) * Patient who has understood the information and agreed to participate in this research by signing the consent form * Patient affiliated to a social security system or entitled person Exclusion Criteria: * Patients with a history of allergy to iodinated contrast material * Patients with MRI contraindications * Patients with a history of allergy to contrast material containing gadolinium * Pregnant or breastfeeding women * Patients under the protection of justice * Patients unable to understand research information in an informed manner * Participation in another interventional therapeutic trial
References
Publications (5)
- BACKGROUNDNault JC, Sutter O, Nahon P, Ganne-Carrie N, Seror O. Percutaneous treatment of hepatocellular carcinoma: State of the art and innovations. J Hepatol. 2018 Apr;68(4):783-797. doi: 10.1016/j.jhep.2017.10.004. Epub 2017 Oct 13. PMID 29031662
- BACKGROUNDYu H, Burke CT. Comparison of percutaneous ablation technologies in the treatment of malignant liver tumors. Semin Intervent Radiol. 2014 Jun;31(2):129-37. doi: 10.1055/s-0034-1373788. PMID 25071303
- BACKGROUNDMonfardini L, Orsi F, Caserta R, Sallemi C, Della Vigna P, Bonomo G, Varano G, Solbiati L, Mauri G. Ultrasound and cone beam CT fusion for liver ablation: technical note. Int J Hyperthermia. 2018;35(1):500-504. doi: 10.1080/02656736.2018.1509237. Epub 2018 Sep 11. PMID 30204007
- BACKGROUNDLee LH, Hwang JI, Cheng YC, Wu CY, Lee SW, Yang SS, Yeh HZ, Chang CS, Lee TY. Comparable Outcomes of Ultrasound versus Computed Tomography in the Guidance of Radiofrequency Ablation for Hepatocellular Carcinoma. PLoS One. 2017 Jan 9;12(1):e0169655. doi: 10.1371/journal.pone.0169655. eCollection 2017. PMID 28068369
- BACKGROUNDCornelis FH, Korenbaum C, Ben Ammar M, Tavolaro S, Nouri-Neuville M, Lotz JP. Multimodal image-guided electrochemotherapy of unresectable liver metastasis from renal cell cancer. Diagn Interv Imaging. 2019 May;100(5):309-311. doi: 10.1016/j.diii.2019.01.001. Epub 2019 Jan 26. No abstract available. PMID 30691970