NCT06333587

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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
117mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Oct 2022Dec 2035

Study Start

First participant enrolled

October 10, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Expected
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

3.2 years

First QC Date

March 21, 2024

Last Update Submit

March 21, 2024

Conditions

Papillary Thyroid Microcarcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Percentage of patients with local recurrence at 10 years

    10 years

  • Percentage of patients with distant metastasis at 10 years

    10 years

  • Percentage of patients died at 10 years

    10 years

Study Arms (1)

image-guided thermal ablation

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

Procedure: image-guided thermal ablation

Interventions

image-guided thermal ablationPROCEDURE

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

image-guided thermal ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients \> 18years
  • Patients with diagnosis of papillary thyroid microcarcinoma, citologically proven, suitable for MITT.
  • Patients must be accessible for follow-up

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Papillary Thyroid Microcarcinoma

Study Officials

  • Giovanni Mauri

    European Institute of Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Mauri

CONTACT

+390294372691giovanni.mauri@ieo.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2024

First Posted

March 27, 2024

Study Start

October 10, 2022

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2035

Last Updated

March 27, 2024

Record last verified: 2024-03

Locations

IT(1)