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Completed

NCT Number: NCT05726981

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

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.

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Key information

Conditions

Thermal Ablation Endocrine Gland Neoplasms Endocrine System Diseases Fine Needle Aspiration Biopsy Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms Thyroid Nodule Thyroid Nodules

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Pitié-Salpêtrière - Department of Thyroid and Endocrine Tumour Pathologies

Paris, 75651, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients > 18 years old
  • 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.
  • Obtaining written informed consent
  • Affiliation to a social security system (excluding AME)

Exclusion criteria

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

Treatment and study plan

Fine needle aspiration biopsy (FNAB)

Procedure

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)

Primary outcomes

  1. Cytological change after thermoablation, as described by the 2017 Bethesda classification in six classes, scale ranging from I to VI.

    Time frame: Day of the Fine Needle Aspiration Biopsy

    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.

Secondary outcomes

  1. Ultrasound description of the nodule: size (length x width x thickness)

    Time frame: Day of the Fine Needle Aspiration Biopsy

  2. Ultrasound description of the nodule: volume (length x width x thickness)

    Time frame: Day of the Fine Needle Aspiration Biopsy

  3. Ultrasound description of the nodule: echogenicity, as compared with the adjacent thyroid and muscular tissues

    Time frame: Day of the Fine Needle Aspiration Biopsy

  4. Ultrasound description of the nodule: echostructure, measured as the percentage of liquid volume compared to nodule's total volume

    Time frame: Day of the Fine Needle Aspiration Biopsy

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: CYTOTHYRAF

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2023
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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