Microwave Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms
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
1 other identifier
observational
500
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2018
CompletedFirst Submitted
Initial submission to the registry
May 27, 2019
CompletedFirst Posted
Study publicly available on registry
June 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
ExpectedApril 12, 2024
April 1, 2024
7.8 years
May 27, 2019
April 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (3)
Overall Survival (OS)
From date of ablation until death from any cause; evaluated up to 5 years
Progression Free Survival (PFS)
From date of ablation until death from any cause; evaluated up to 5 years
Organ specific Progression Free Survival (PFS)
From date of ablation until death from any cause; evaluated up to 5 years
Study Arms (2)
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
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
Interventions
Thermal ablation
Eligibility Criteria
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.
You may qualify if:
- \> 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
You may not qualify if:
- pregnant women
- non-manageable coagulopathies
- Extended extrahepatic or extrarenal disease
- for liver ablation: presence of bilio-digestive anastomosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Ospedale San Raffaele
Milan, 20153, Italy
Related Publications (2)
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.
PMID: 28220346BACKGROUNDdi Gaeta E, Olivieri M, Savi A, Magnani P, Canevari C, Gusmini S, Palumbo D, Guazzarotti G, Augello L, Calabrese F, Steidler S, Cipriani F, Rimini M, Casadei-Gardini A, Aldrighetti L, Chiti A, De Cobelli F. Radioembolization for Hepatocellular Carcinoma: a Comparison on Dual-phase Cone-beam CT, Contrast-enhanced CT (CECT) and 99mTc-macroaggregated albumin-SPECT/CT in predicting final distribution volumes and dosimetry of the post-embolization 90Y PET/CT. Radiol Med. 2025 Apr;130(4):474-485. doi: 10.1007/s11547-024-01946-0. Epub 2024 Dec 20.
PMID: 39707126DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Radiology, Clinical and Experimental Radiology
Study Record Dates
First Submitted
May 27, 2019
First Posted
June 10, 2019
Study Start
February 28, 2018
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2030
Last Updated
April 12, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share