Clinical trial NCT05726981: Ultrasound and Cytological Evaluation 3 Years After Radiofrequency Thermal Ablation of Benign Thyroid Nodules : a Prospective Exploratory Cohort of 180 Nodules
Official title: Ultrasound and Cytological Evaluation 3 Years After Radiofrequency Thermal Ablation of Benign Thyroid Nodules : a Prospective Exploratory Cohort of 180 Nodules
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thermal Ablation
Fine Needle Aspiration Biopsy
Thyroid Nodules
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Patients \> 18 years old
2. Carrier of a benign thyroid nodule that has undergone radiofrequency thermoablation 36 months previously ± 12 months, 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)

Primary outcomes:
measure: Cytological change after thermoablation, as described by the 2017 Bethesda classification in six classes, scale ranging from I to VI.
timeFrame: Day of the Fine Needle Aspiration Biopsy
Secondary outcomes:
measure: Ultrasound description of the nodule: size (length x width x thickness)
timeFrame: Day of the Fine Needle Aspiration Biopsy
measure: Ultrasound description of the nodule: volume (length x width x thickness)
timeFrame: Day of the Fine Needle Aspiration Biopsy
measure: Ultrasound description of the nodule: echogenicity, as compared with the adjacent thyroid and muscular tissues
timeFrame: Day of the Fine Needle Aspiration Biopsy
measure: Ultrasound description of the nodule: echostructure, measured as the percentage of liquid volume compared to nodule's total volume
timeFrame: Day of the Fine Needle Aspiration Biopsy
Other outcomes:
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