An interventional study of Fine needle aspiration biopsy (FNAB) in Thermal Ablation, Fine Needle Aspiration Biopsy and Thyroid Nodules, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
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.
200 studies on the registry are indexed under Thyroid Nodule; 57 are open to participants now.
This study's enrollment of 85 is close to the median of 81 across 118 interventional studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
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)
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.
Time frame: Day of the Fine Needle Aspiration Biopsy
Ultrasound description of the nodule: size (length x width x thickness)
Time frame: Day of the Fine Needle Aspiration Biopsy
Ultrasound description of the nodule: volume (length x width x thickness)
Time frame: Day of the Fine Needle Aspiration Biopsy
Ultrasound description of the nodule: echogenicity, as compared with the adjacent thyroid and muscular tissues
Time frame: 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
Time frame: Day of the Fine Needle Aspiration Biopsy
Plan to share: Undecided
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Assistance Publique - Hôpitaux de Paris