Minimally Invasive Treatments of the Thyroid

Recruiting

• Conditions: Papillary Thyroid Microcarcinoma
• Interventions: Procedure: image-guided thermal ablation

• Registration Number: NCT06333587
• Lead Sponsor: European Institute of Oncology

Brief Summary

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)

Detailed Description

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 Timeline

• Study Start: 2022-10-10
• Status Verified: 2024-03
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-21
• Last Update Submitted: 2024-03-21
• Study First Posted: 2024-03-27
• Last Update Posted: 2024-03-27
• Primary Completion: 2025-12-31
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The proportion of patients with major complications occurring within one month after the date of intervention	1 month	Complications will be reported according to modified Society of Interventional Radiology (SIR) classification

Secondary Outcome Measures

Name	Time	Method
Percentage of patients died at 10 years	10 years	Evaluation of Overall Survival (OS): Percentage of patients died at 10 years
Percentage of patients with distant metastasis at 10 years	10 years	Evaluation of disease free survival (DFS): percentage of patient whith distant metastasis at 10 years of follow up
Percentage of patients with local recurrence at 10 years	10 years	Evaluation of disease free survival (DFS): percentage of patient whith a local recurrence at 10 years of follow up

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy