Microwave Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms

Sponsor

Francesco De Cobelli (Other)

Overall Status

Recruiting

CT.gov ID

NCT03981497

Collaborator

(none)

500

Enrollment

Location

154.1

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cancer Liver Metastasis Colon Cancer Kidney Cancer Renal Cell Carcinoma	Procedure: Microwave ablation (MWA)

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Retrospective and Perspective Analysis of Short, Medium and Long Term Clinical Performance of Patients Undergoing MicrowaveThermal Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms

Actual Study Start Date :

Feb 28, 2018

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Small Renal Tumors Subjects with small renal tumors (SRT) ad described by current ESMO (European Society for Medical Oncology) guidelines who are candidates for MWA	Procedure: Microwave ablation (MWA) Thermal ablation
Primary and Secondary Liver cancer Primary liver tumors: subjects who are candidates for MWA with nodules ≤ 3 cm Liver metastases: subjects who are candidates for MWA with nodules less than ≤ 3 cm	Procedure: Microwave ablation (MWA) Thermal ablation

Arm

Intervention/Treatment

Small Renal Tumors

Subjects with small renal tumors (SRT) ad described by current ESMO (European Society for Medical Oncology) guidelines who are candidates for MWA

Procedure: Microwave ablation (MWA)

Thermal ablation

Primary and Secondary Liver cancer

Primary liver tumors: subjects who are candidates for MWA with nodules ≤ 3 cm Liver metastases: subjects who are candidates for MWA with nodules less than ≤ 3 cm

Procedure: Microwave ablation (MWA)

Thermal ablation

Outcome Measures

Primary Outcome Measures

Local Tumor Progression Free Survival [From date of ablation until death from any cause; evaluated up to 5 years]
Based on imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins)
Time to Local Progression [From date of ablation until death from any cause; evaluated up to 5 years]
Time from ablation to imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins)

Secondary Outcome Measures

Overall Survival (OS) [From date of ablation until death from any cause; evaluated up to 5 years]
From date of ablation until death for any cause
Progression Free Survival (PFS) [From date of ablation until death from any cause; evaluated up to 5 years]
From date of ablation until any documented evidence of tumor progression at any site
Organ specific Progression Free Survival (PFS) [From date of ablation until death from any cause; evaluated up to 5 years]
From date of ablation until any documented evidence of tumor progression at the ablated organ (including reccurence at ablation site)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Ospedale San Raffaele	Milano		Italy	20153

Sponsors and Collaborators

Francesco De Cobelli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Francesco De Cobelli, Professor of Radiology, Head of Clinical and Experimental Radiology, IRCCS San Raffaele

ClinicalTrials.gov Identifier:

NCT03981497

Other Study ID Numbers:

MWA-01

First Posted:

Jun 10, 2019

Last Update Posted:

Jan 19, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Francesco De Cobelli, Professor of Radiology, Head of Clinical and Experimental Radiology, IRCCS San Raffaele

MWA

Additional relevant MeSH terms:

Neoplasms

Carcinoma, Renal Cell

Liver Neoplasms

Kidney Neoplasms

Study Results

No Results Posted as of Jan 19, 2022