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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microwave ablation (MWA) | Procedure | Thermal ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | 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) | From date of ablation until any documented evidence of tumor progression at any site |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco De Cobelli, MD | Contact | +390226432529 | decobelli.francesco@hsr.it | |
| Stephanie Steidler, PhD | Contact | +3926432529 | steidler.stephanie@hsr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele | Recruiting | Milan | 20153 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28220346 | Background | 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. | |
| 39707126 |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| 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) | From date of ablation until death from any cause; evaluated up to 5 years |
| Derived |
| 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. |
| D008107 |
| Liver Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |