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

NCT ID: NCT03981497

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-28

Study Completion Date

2030-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Liver Cancer Liver Metastasis Colon Cancer Kidney Cancer Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

Microwave ablation (MWA)

Intervention Type PROCEDURE

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

Microwave ablation (MWA)

Intervention Type PROCEDURE

Thermal ablation

Interventions

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Microwave ablation (MWA)

Thermal ablation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Francesco De Cobelli

OTHER

Sponsor Role lead

Responsible Party

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Francesco De Cobelli

Professor of Radiology, Clinical and Experimental Radiology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesco De Cobelli, MD

Role: CONTACT

+390226432529

Stephanie Steidler, PhD

Role: CONTACT

+3926432529

Facility Contacts

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Francesco De Cobelli

Role: primary

Stephanie Steidler, PhD

Role: backup

+390226432529

References

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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.

Reference Type BACKGROUND
PMID: 28220346 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39707126 (View on PubMed)

Other Identifiers

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MWA-01

Identifier Type: -

Identifier Source: org_study_id

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