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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03981497
Other study ID # MWA-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 28, 2018
Est. completion date December 31, 2030

Study information

Verified date April 2024
Source IRCCS San Raffaele
Contact Francesco De Cobelli, MD
Phone +390226432529
Email decobelli.francesco@hsr.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to collect data on efficacy and safety of microwave ablation (MWA) used to treat subjects with primary and secondary liver malignancies and renal malignancies. The main question it aims to evaluate the short, medium and long-term clinical course of patients treated with MWA. Participants will not alter their normal clinical and therapeutic practice, due to the observational nature of the study, and all data regarding microwave treatments will be collected (including demographic data). follow their normal clinical and therapeutic path


Description:

Observational, retrospective and prospective, monocentric study. The objective is to evaluate the short, medium and long-term clinical course of patients undergoing microwave ablation (MWA) for small renal tumors and primary and secondary liver neoplasms. Evaluation of clinical efficacy (progression free survival),safety and technical outcome of microwave ablation as well as clinical outcome of the procedure will be evaluated.At the end of the follow-up periods, the data collected will be compared with those available in the literature on MWA, cryoablation (CA), radiofrequency ablation (RFA) and surgical resection.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2030
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - > 18 years with primary or secondary liver tumors or small kidney tumors that are not candidates for surgery or cannot be radically resected by surgery alone - Primary liver cancer: up to three liver nodules = 3 cm - Secondary hepatic tumours: up to nodules = 3 cm provided that the objective is complete hepatic clearance Renal tumours: single or multiple (von Hippel Lindau syndrome), < 4 cm Exclusion Criteria: - pregnant women - non-manageable coagulopathies - Extended extrahepatic or extrarenal disease - for liver ablation: presence of bilio-digestive anastomosis

Study Design


Intervention

Procedure:
Microwave ablation (MWA)
Thermal ablation

Locations

Country Name City State
Italy IRCCS Ospedale San Raffaele Milano

Sponsors (1)

Lead Sponsor Collaborator
Francesco De Cobelli

Country where clinical trial is conducted

Italy, 

References & Publications (1)

De Cobelli F, Marra P, Ratti F, Ambrosi A, Colombo M, Damascelli A, Sallemi C, Gusmini S, Salvioni M, Diana P, Cipriani F, Venturini M, Aldrighetti L, Del Maschio A. Microwave ablation of liver malignancies: comparison of effects and early outcomes of percutaneous and intraoperative approaches with different liver conditions : New advances in interventional oncology: state of the art. Med Oncol. 2017 Apr;34(4):49. doi: 10.1007/s12032-017-0903-8. Epub 2017 Feb 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Local Tumor Progression Free Survival Based on imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins) From date of ablation until death from any cause; evaluated up to 5 years
Primary Time to Local Progression Time from ablation to imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins) From date of ablation until death from any cause; evaluated up to 5 years
Secondary Overall Survival (OS) From date of ablation until death for any cause From date of ablation until death from any cause; evaluated up to 5 years
Secondary Progression Free Survival (PFS) From date of ablation until any documented evidence of tumor progression at any site From date of ablation until death from any cause; evaluated up to 5 years
Secondary Organ specific Progression Free Survival (PFS) From date of ablation until any documented evidence of tumor progression at the ablated organ (including reccurence at ablation site) From date of ablation until death from any cause; evaluated up to 5 years
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