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

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Fine Needle Aspiration Biopsy; Thermal Ablation; Thyroid Nodules

Treatments: Procedure: Fine needle aspiration biopsy (FNAB)

Study type: Interventional

Funder types: Other

Identifiers

NCT05726981

APHP211436

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 1 patient group

Patients with nodules treated by thermal ablation

Experimental group

Description:

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.

Treatment:

Procedure: Fine needle aspiration biopsy (FNAB)