Minimally Invasive Treatments of the Thyroid (MIPA-MITT)

• ClinicalTrials.gov Identifier: NCT06333587
• Recruitment Status: Recruiting
• First Posted: March 27, 2024
• Last Update Posted: March 27, 2024
• Sponsor: European Institute of Oncology
• Information provided by (Responsible Party): European Institute of Oncology

Tracking Information

• First Submitted Date: March 21, 2024
• First Posted Date: March 27, 2024
• Last Update Posted Date: March 27, 2024
• Actual Study Start Date: October 10, 2022
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 21, 2024)

The proportion of patients with major complications occurring within one month after the date of intervention [ Time Frame: 1 month ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 21, 2024)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Minimally Invasive Treatments of the Thyroid
• Official Title: Multicenter International Prospective Analysis on Minimally Invasive Treatments of the Thyroid (MIPA- MITT) of of Micropapillary Thyroid Carcinoma
• 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 Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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
• Condition: Papillary Thyroid Microcarcinoma

Intervention

Procedure: image-guided thermal ablation

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

Study Groups/Cohorts

image-guided thermal ablation

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

Intervention: Procedure: image-guided thermal ablation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 21, 2024): 270
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2035
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Giovanni Mauri; +390294372691; giovanni.mauri@ieo.it

• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT06333587
• Other Study ID Numbers: IEO 1810
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: European Institute of Oncology
• Original Responsible Party: Same as current
• Current Study Sponsor: European Institute of Oncology
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Giovanni Mauri; European Institute of Oncology

• PRS Account: European Institute of Oncology
• Verification Date: March 2024