Minimally Invasive Treatments of the Thyroid

NCT ID: NCT06333587

Last Updated: 2024-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-10

Study Completion Date

2035-12-31

Brief Summary

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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

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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.

Conditions

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Papillary Thyroid Microcarcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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image-guided thermal ablation

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

image-guided thermal ablation

Intervention Type PROCEDURE

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

Interventions

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image-guided thermal ablation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giovanni Mauri

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

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European Institute of Oncology

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giovanni Mauri

Role: CONTACT

+390294372691

Facility Contacts

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Giovanni Mauri

Role: primary

Other Identifiers

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IEO 1810

Identifier Type: -

Identifier Source: org_study_id

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