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RecruitingNCT03981497Updated Sep 23, 2026

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

An observational study in Liver Cancer, Liver Metastasis Colon Cancer and Kidney Cancer, sponsored by Francesco De Cobelli. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Francesco De Cobelli · Observational

From the registry’s dates

  • Started Feb 2018; still recruiting 8 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
500
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 79 studies in Liver Neoplasms with a site in Italy — 17 open to participants now, 26 under way, 4 of them phase 3. Liver Neoplasms · Italy.

Planned enrollment
12th of 25
500 · median 500
Started
2018
with 5 others
Observational
26 of 79
10 open now
Primary completion
2034-12
later than 21 of 25 live
Registered
49th of 79
by date

Among the 79 studies in Liver Neoplasms with a site in Italy, this one is the 12th largest by planned enrollment of the 25 observational ones, is one of 6 that started in 2018, is one of 26 observational ones, reaches primary completion later than 21 of the 25 other live ones, and was the 49th registered.

By phase

79 studies; the count open now beside each. This study's row is marked.

Observationalthis study26 · 10 open
Phase 320 · 0 open
No phase15 · 6 open
Phase 28 · 0 open
Phase 16 · 1 open
Phase 1/24 · 0 open

By the year they started

First in 1998; this study’s year is marked. 6 started in 2018.

Size and results

Median enrollment 140 across the 53 interventional studies, 500 across the 25 observational. Of the 46 that completed or were terminated, 17 (37%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 79 studies in Liver Neoplasms with a site in Italy, or all of them as a file.
02

Study 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

Read the 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.

03

Conditions studied

  • Liver Cancer
  • Liver Metastasis Colon Cancer
  • Kidney Cancer
  • Renal Cell Carcinoma

Keywords

  • MWA
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • pregnant women
  • non-manageable coagulopathies
  • Extended extrahepatic or extrarenal disease
  • for liver ablation: presence of bilio-digestive anastomosis
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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)

  • 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)

Interventions

  • ProcedureMicrowave ablation (MWA)

    Thermal ablation

06

What researchers measure

Primary outcomes

  1. Local Tumor Progression Free Survival

    Based on imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins)

    Time frame: From date of ablation until death from any cause; evaluated up to 5 years

  2. Time to Local Progression

    Time from ablation to imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins)

    Time frame: From date of ablation until death from any cause; evaluated up to 5 years

Secondary outcomes

  1. Overall Survival (OS)

    From date of ablation until death for any cause

    Time frame: From date of ablation until death from any cause; evaluated up to 5 years

  2. Progression Free Survival (PFS)

    From date of ablation until any documented evidence of tumor progression at any site

    Time frame: From date of ablation until death from any cause; evaluated up to 5 years

  3. 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)

    Time frame: From date of ablation until death from any cause; evaluated up to 5 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 28220346 ↗
  • di 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. PubMed 39707126 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2018 (actual). Primary completion is estimated for Dec 2034, 202 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 27, 2019
First posted
Jun 10, 2019
StartActual
Feb 28, 2018
Primary completionEst.
Dec 31, 2034
CompletionEst.
Dec 31, 2039
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03981497
Lead sponsor
Francesco De Cobelli
Responsible party
Francesco De Cobelli (Professor of Radiology, Clinical and Experimental Radiology, IRCCS San Raffaele) — Sponsor-investigator
First posted
Jun 10, 2019
Start date
Feb 28, 2018
Primary completion
Dec 31, 2034 (estimated)
Completion
Dec 31, 2039 (estimated)
Last update
Sep 23, 2026

Study contacts

Francesco De Cobelli, MD
Contact
decobelli.francesco@hsr.it
+390226432529
Stephanie Steidler, PhD
Contact
steidler.stephanie@hsr.it
+3926432529

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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