Minimally Invasive Treatments of the Thyroid

European Institute of Oncology270 enrolled

Overview

This is a prospective cohort study to test Minimally Invasive Treatments of the Thyroid (MITT) as potential alternative to surgery in patients with Papillary Thyroid MicroCarcinoma (PTMC)

Image-guided thermal ablations have been successfully applied in the treatment of several type of tumors, and have been recently proposed as a potential alternative to surgery also in patients with thyroid diseases, and named "Minimally Invasive Treatments of the Thyroid (MITT)". These minimally invasive treatments, compared to surgical treatment have similar efficacy, fewer complications, better quality of life, and better cosmetic outcomes. These procedures allow precise delivery of the heat locally to the lesion, sparing the surrounding thyroid tissue, and thus minimizing the invasiveness of the treatment and the impact on thyroid function. This study aim to establish a prospective registry of the cases of patients treated with MITT for a Papillary Thyroid MicroCarcinoma (PTMC), in order to validate the safety of the procedure and to set the basis for collecting long term results in a large cohort of patients.

Study Type

OBSERVATIONAL

Enrollment

270

Conditions

Papillary Thyroid Microcarcinoma

Interventions

image-guided thermal ablationPROCEDURE

image-guided thermal ablation in patients with diagnosis of micropapillary thyroid carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients \> 18years * Patients with diagnosis of papillary thyroid microcarcinoma, citologically proven, suitable for MITT. * Written informed consent must be signed and dated by the patient and the investigator prior to inclusion. * Patients must be accessible for follow-up Exclusion Criteria: * Tumors \> 1 cm, other citological type, refusal of MITT, unsuitable for MITT, unmanageable coagulative disorders * Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study

Locations (1)

European Institute of Oncology

Milan, Italy

RECRUITING

Outcomes

Primary Outcomes

The proportion of patients with major complications occurring within one month after the date of intervention

Complications will be reported according to modified Society of Interventional Radiology (SIR) classification

Time frame: 1 month

Secondary Outcomes

Percentage of patients with local recurrence at 10 years

Evaluation of disease free survival (DFS): percentage of patient whith a local recurrence at 10 years of follow up

Time frame: 10 years

Percentage of patients with distant metastasis at 10 years

Evaluation of disease free survival (DFS): percentage of patient whith distant metastasis at 10 years of follow up

Time frame: 10 years

Percentage of patients died at 10 years

Evaluation of Overall Survival (OS): Percentage of patients died at 10 years

Time frame: 10 years

Central Contacts

Giovanni Mauri

CONTACT

+390294372691 giovanni.mauri@ieo.it

Data from ClinicalTrials.gov

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