Liver CancerNCT03981497
Microwave Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms
An observational study of Liver Cancer and Liver Metastasis Colon Cancer, run by Francesco De Cobelli at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Liver Metastasis Colon Cancer, Kidney Cancer
- What is being tested?
- Microwave ablation (MWA)
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 28 Feb 2018to 31 Dec 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- > 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
Who cannot join
- pregnant women
- non-manageable coagulopathies
- Extended extrahepatic or extrarenal disease
- for liver ablation: presence of bilio-digestive anastomosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, 20153
Francesco De Cobelli, decobelli.francesco@hsr.it
Stephanie Steidler, PhD, +390226432529, steidler.stephanie@hsr.it
About this study
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
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.
- Being tested
- Microwave ablation (MWA)
- Keywords
- MWA
- Medical subject headings
- Liver Neoplasms, Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave ablation (MWA)Procedure or surgery
Thermal ablation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Microwave ablation (MWA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Tumor Progression Free Survival
Based on imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins)
Measured: 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)
Measured: 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 for any cause
Measured: From date of ablation until death from any cause; evaluated up to 5 years
Progression Free Survival (PFS)
From date of ablation until any documented evidence of tumor progression at any site
Measured: 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 any documented evidence of tumor progression at the ablated organ (including reccurence at ablation site)
Measured: From date of ablation until death from any cause; evaluated up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start28 Feb 2018
- Primary completion31 Dec 2034 (estimated)
- Study completion31 Dec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francesco De Cobelli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francesco De Cobelli, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981497
- Sponsor's protocol ID
- MWA-01
- Status last verified
- Sep 2026
- First submitted
- 27 May 2019
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 28220346di 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03981497
- Acronym / sponsor ID
- MWA-01
- Keywords
- MWA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Francesco De CobelliUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 31 Dec 2034 (estimated)
- Study completion
- 31 Dec 2039 (estimated)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small Renal Tumors | – | Procedure: Microwave ablation (MWA)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 | – | Procedure: Microwave ablation (MWA)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- > 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
Key exclusion criteria (4 listed)
- pregnant women
- non-manageable coagulopathies
- Extended extrahepatic or extrarenal disease
- for liver ablation: presence of bilio-digestive anastomosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave ablation (MWA)Thermal ablation | Procedure or surgery | Primary and Secondary Liver cancer, Small Renal Tumors |
Primary outcome
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)
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)
3 secondary outcomes
Overall Survival (OS)
Time frame: 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
Organ specific Progression Free Survival (PFS)
Time frame: From date of ablation until death from any cause; evaluated up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 28220346De 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.
- Derived from this study: PubMed 39707126di 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer and Liver Metastasis Colon Cancer, run by Francesco De Cobelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco De Cobelli, MD (+390226432529, decobelli.francesco@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Tumor Progression Free Survival (time frame: From date of ablation until death from any cause; evaluated up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03981497, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.