Minimally Invasive Treatments of the Thyroid

Papillary Thyroid Microcarcinoma Clinical Trial

— MIPA-MITT  

Official title:

Multicenter International Prospective Analysis on Minimally Invasive Treatments of the Thyroid (MIPA- MITT) of of Micropapillary Thyroid Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06333587
• Other study ID #: IEO 1810
• Status: Recruiting
• Start date: October 10, 2022
• Est. completion date: December 31, 2035

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: Giovanni Mauri
• Phone: +390294372691
• Email: giovanni.mauri[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: December 31, 2035
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Papillary Thyroid Microcarcinoma
• Thyroid Diseases

Intervention

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

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 month
Secondary	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	10 years
Secondary	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	10 years
Secondary	Percentage of patients died at 10 years	Evaluation of Overall Survival (OS): Percentage of patients died at 10 years	10 years