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

April 11, 2024 updated by: Francesco De Cobelli

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milano, Italy, 20153
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Paolo Marra, MD
        • Sub-Investigator:
          • Michele Colombo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects with indication of laparoscopic or percutaneous ablation of primary or secondary liver tumors and small primary kidney tumors (according to ESMO guidelines).

All patients will follow their normal therapeutic procedure and no examination will be added to what is already provided for in the normal management of patients suffering from these diseases.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Tumor Progression Free Survival
Time Frame: 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)
From date of ablation until death from any cause; evaluated up to 5 years
Time to Local Progression
Time Frame: 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)
From date of ablation until death from any cause; evaluated up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From date of ablation until death from any cause; evaluated up to 5 years
From date of ablation until death for any cause
From date of ablation until death from any cause; evaluated up to 5 years
Progression Free Survival (PFS)
Time Frame: 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
From date of ablation until death from any cause; evaluated up to 5 years
Organ specific Progression Free Survival (PFS)
Time Frame: 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)
From date of ablation until death from any cause; evaluated up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Francesco De Cobelli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2018

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

May 27, 2019

First Submitted That Met QC Criteria

June 7, 2019

First Posted (Actual)

June 10, 2019

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MWA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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