Minimally Invasive Treatments of the Thyroid (MIPA-MITT)

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

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)

Study Overview

• Status: Recruiting
• Conditions: Papillary Thyroid Microcarcinoma
• Intervention / Treatment: Procedure: image-guided thermal ablation

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 Type: Observational
• Enrollment (Estimated): 270

Contacts and Locations

• Study Contact: Name: Giovanni Mauri; Phone Number: +390294372691; Email: giovanni.mauri@ieo.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • European Institute of Oncology
    • Contact: Giovanni Mauri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with thyroid diseases suitable for "Minimally Invasive Treatments of the Thyroid (MITT)" as potential alternative to surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
image-guided thermal ablation; image-guided thermal ablation in patients with diagnosis of micropapillary thyroid carcinoma	Procedure: image-guided thermal ablation; image-guided thermal ablation in patients with diagnosis of micropapillary thyroid carcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Percentage of patients died at 10 years	Evaluation of Overall Survival (OS): Percentage of patients died at 10 years	10 years

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Giovanni Mauri, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: IEO 1810

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No