Ultrasound and Cytological Evaluation 3 Years After Radiofrequency Thermal Ablation of Benign Thyroid Nodules : a Prospective Exploratory Cohort of 180 Nodules (CYTOTHYRAF)

There is no scientific data on post-thermal ablation cytological aspects, but treated nodules that grow back significantly after a procedure justify a new cytology in order not to ignore a neoplastic process.

The EU-TIRADS classification usually used to stratify the risk of cancer (and to justify a fine needle aspiration biopsy) of thyroid nodules is not validated for nodules treated by thermal ablation (TA) (post-RF nodules). However, these nodules often acquire ultrasound criteria of suspicion making it necessary to develop an ultrasound stratification of the risk of malignancy specific to nodules treated by TA.

The objective of this work is to describe the ultrasound and cytological aspects of these treated nodules by performing a systematic assessment at 3 years after thermal ablation including systematic neck ultrasound and fine needle aspiration biopsy. Thus, an ultrasound and cytological atlas (Bethesda classification 2017) of nodules treated by thermal ablation will be constituted.

Study Overview

• Status: Recruiting
• Conditions: Thermal Ablation; Thyroid Nodules; Fine Needle Aspiration Biopsy
• Intervention / Treatment: Procedure: Fine needle aspiration biopsy (FNAB)

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adrien BEN HAMOU, MD-PhD; Phone Number: +33 01 84 82 77 59; Email: adrien.benhamou@hotmail.fr
• Study Contact Backup: Name: Camille BUFFET, MD-PhD; Phone Number: +33 01 84 82 77 59; Email: camille.buffet@aphp.fr

Study Locations

• France
  • Paris, France, 75651
    • Recruiting
    • Hospital Pitié-Salpêtrière - Department of Thyroid and Endocrine Tumour Pathologies
    • Contact: Adrien BEN HAMOU, MD-PhD; Phone Number: +33 01 84 82 77 59; Email: adrien.benhamou@hotmail.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients > 18 years old
2. Carrier of a benign thyroid nodule that has undergone radiofrequency thermoablation 36 months previously ± 12 months +/- 1 month, whether the nodule is stable, progressing or decreasing in volume during the screening period and/or on the day of inclusion.
3. Obtaining written informed consent
4. Affiliation to a social security system (excluding AME)

Exclusion Criteria:

1. Pregnant or breastfeeding women
2. Previous alcohol use
3. Patients on anti-vitamin K anticoagulants
4. Patients on direct oral anticoagulants
5. Persons deprived of liberty by judicial or administrative decision
6. Persons under forced psychiatric care
7. Persons admitted to a health or social institution for purposes other than research
8. Persons of full age who are under legal protection (guardianship or curatorship)
9. Persons unable to express their consent
10. Persons under a legal protection measure (there can be no derogation for this category)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with nodules treated by thermal ablation; The study population is a monocentric cohort of patients who underwent thermoablation treatment for benign thyroid nodules 3 years ago. These patients aged >18 years-old were carriers of a benign but troublesome thyroid nodule before thermal ablation, either unique or "dominant", i.e. associated with one or more other non-significant nodules (<20 mm) that were subjected to simple ultrasound surveillance. Patients refused, after clear and fair information, surgical management of their nodule. On average, 2 patients have been treated for TA per week in the Thyroid Disease and Endocrine Tumor Department since 2016. Patients systematically benefit from annual clinical and ultrasound monitoring as part of their follow-up in our Department.

Procedure: Fine needle aspiration biopsy (FNAB); Thyroid FNAB is a minimally invasive procedure performed routinely by an experienced sonographer. It is a safe and brief procedure, performed with a 27G or 25G (very fine) needle (3 needles, i.e. 1 needle per pass)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cytological change after thermoablation, as described by the 2017 Bethesda classification in six classes, scale ranging from I to VI.	Cytological result of the nodule 3 years after thermoablation, the result of which is given according to the 2017 Bethesda classification in six classes ranging from I to VI.	Day of the Fine Needle Aspiration Biopsy

Secondary Outcome Measures

Outcome Measure	Time Frame
Ultrasound description of the nodule: size (length x width x thickness)	Day of the Fine Needle Aspiration Biopsy
Ultrasound description of the nodule: volume (length x width x thickness)	Day of the Fine Needle Aspiration Biopsy
Ultrasound description of the nodule: echogenicity, as compared with the adjacent thyroid and muscular tissues	Day of the Fine Needle Aspiration Biopsy
Ultrasound description of the nodule: echostructure, measured as the percentage of liquid volume compared to nodule's total volume	Day of the Fine Needle Aspiration Biopsy

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2023
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Nodule; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Cytological Techniques; Biopsy; Cytodiagnosis; Diagnostic Techniques, Surgical; Biopsy, Needle; Biopsy, Fine-Needle
• Other Study ID Numbers: APHP211436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No