Study of Automatic Image Fusion of a CT Volume With Ultrasound During Percutaneous Ablation Treatment of Hepatic Tumors

NCT04420026 | Completed

• 2 other identifiers: APHP1905812019-A02524-53
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hepatocellular Carcinoma

Keywords

ablation; cone-beam CT volume; ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  At 1 month on post-operative imaging

Secondary Outcomes (10)

• Evaluate the time savings when using "INTERACT Active Tracker" allowing automatic alignment of the CBCT volume with ultrasound

  The day of the operation

• Evaluate the time saved by using "INTERACT Active Tracker" allowing automatic alignment of the CBCT volume with ultrasound compared to the manual alignment procedure performed on a series of patients treated when the new function was not available.

  The day of the operation

• Evaluate the confidence gain associated with the use of ultrasound fusion.

  The day of the operation

• Evaluate the accuracy of the automatic alignment judged on the ultrasound measurement of the distance from the center of the target seen in ultrasound to that segmented on the pre-therapeutic pour Cone Beam Computed Tomography (CBCT).

  The day of the operation

• Evaluate the percentage of procedures for which similarity points must be added due to an initial delay in automatic merging that the operator considers too long.

  The day of the operation

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Hepatocellular tumours

Radiation: Interact Active Tracker

Interventions

Interact Active Tracker RADIATION

Interact Active Tracker, allowing the automation of the fusion between a CBCT and ultrasound imaging

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• General Electric: collaborator

Study Sites (1)

SERROR

Bobigny, 93000, France

Location

Related Publications (5)

• Nault 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 BACKGROUND

• Yu 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 BACKGROUND

• Monfardini 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 BACKGROUND

• Lee 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 BACKGROUND

• Cornelis 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 BACKGROUND

Related Links

• Minimally Invasive Treatments for Liver Cancer, Updates in Liver Cancer. Nicolas Cardenas, Rahul Sheth and Joshua Kuban.

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

• Olivier Mr SEROR, PhD

  Assistance Publique - Hôpitaux Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: June 9, 2020
• Study Start: July 6, 2020
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-09

Locations

FR (1)