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NCT Number: NCT06333587

Minimally Invasive Treatments of the Thyroid

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)

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

European Institute of Oncology

Milan, Italy

Location status: Recruiting

Location contact

Giovanni Mauri

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

image-guided thermal ablation

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Percentage of patients died at 10 years

    Time frame: 10 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Mauri

CONTACT

[email protected]

+390294372691

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

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

Acronym: MIPA-MITT

Important dates

Study start
2022
Primary completion
2025
Study completion
2035
First posted
Mar 27, 2024
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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