NCT05765695

Brief Summary

The goal of this clinical trial is to demonstrate that TIR3A nodules with negative genetic test can be safely and effectively treated by radiofrequency ablation, with nodular shrinkage and improvement of clinical symptoms. Fine needle aspiration cytology is the gold standard test for differential diagnosis of thyroid nodules, but sometimes the result can be indeterminate with a risk of malignancy of 10-30%. In these cases the ablation is not indicated and many patients with benign nodules that may benefit from the procedure are not treated. All the patients enrolled must have a TIR3A cytology and negative genetic test for mutations associated with thyroid carcinoma. Before the ablation blood, evaluation of serum TSH, anti-thyroglobulin antibodies, anti-thyroid peroxidase antibodies and calcitonin levels will be performed.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

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 Start

First participant enrolled

January 10, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

4 years

First QC Date

February 27, 2023

Last Update Submit

April 15, 2024

Conditions

Thyroid Nodule

Keywords

thyroid noduleindeterminategeneticradiofrequency ablationfollow-up

Outcome Measures

Primary Outcomes (7)

  • Thyroid nodule volume reduction rate

    The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline

    1 month after the procedure

  • Thyroid nodule volume reduction rate

    The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline

    6 months after the procedure

  • Thyroid nodule volume reduction rate

    The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline

    12 months after the procedure

  • Complication rate

    Assessment of the complications of the procedure and over time

    When the procedure is performed

  • Complication rate

    Assessment of the complications of the procedure and over time

    1 month after the procedure

  • Complication rate

    Assessment of the complications of the procedure and over time

    6 months after the procedure

  • Complication rate

    Assessment of the complications of the procedure and over time

    12 months after the procedure

Study Arms (1)

Treated group

EXPERIMENTAL
Procedure: Radiofrequency ablation performed with a 19 gauge STARmed needle.

Interventions

Radiofrequency ablation performed with a 19 gauge STARmed needle.PROCEDURE

The ablation with radiofrequency is a safe and effective minimally invasive procedure that results in thermal tissue necrosis. A needle electrode is inserted into the thyroid nodule using ultrasound guidance and generates heat by alternating electric current causing thermal injury. Afterwards, the ablated tissue is gradually absorbed with progressive shrinkage of the nodule.

Treated group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with thyroid nodule eligible for radiofrequency ablation, with low-risk indeterminate lesion cytology (TIR3A) and negative genetic test for mutations associated with thyroid carcinoma

You may not qualify if:

  • Patients who are not able to sign the informed consent
  • Patients with contraindications to radiofrequency ablation
  • Patients with cytology different from TIR3A
  • Patients with positive genetic test for mutations associated with thyroid carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, 20149, Italy

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Central Study Contacts

Laura Fugazzola

CONTACT

+390261911l.fugazzola@auxologico.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 13, 2023

Study Start

January 10, 2021

Primary Completion

January 10, 2025

Study Completion

January 10, 2025

Last Updated

April 16, 2024

Record last verified: 2024-04

Locations

IT(1)