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NCT Number: NCT03981497

Microwave 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

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Key information

Conditions

Liver Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Cancer Kidney Diseases Kidney Neoplasms Liver Diseases Liver Metastasis Colon Cancer Liver Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Renal Cell Carcinoma Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, 20153, Italy

Location status: Recruiting

Location contact

Francesco De Cobelli

CONTACT

[email protected]

Michele Colombo, MD

SUB_INVESTIGATOR

Paolo Marra, MD

SUB_INVESTIGATOR

Stephanie Steidler, PhD

CONTACT

[email protected]

+390226432529

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microwave Ablation (MWA)

Procedure

Thermal ablation

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Overall Survival (OS)

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

    From date of ablation until death for any cause

  2. Progression Free Survival (PFS)

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

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

  3. Organ specific Progression Free Survival (PFS)

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

    From date of ablation until any documented evidence of tumor progression at the ablated organ (including reccurence at ablation site)

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco De Cobelli, MD

CONTACT

[email protected]

+390226432529

Stephanie Steidler, PhD

CONTACT

[email protected]

+3926432529

Sponsors and collaborators

Lead sponsor

Francesco De Cobelli

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2025
Study completion
2030
First posted
Jun 10, 2019
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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