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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05726981
Other study ID # APHP211436
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2023
Est. completion date January 2025

Study information

Verified date January 2023
Source Assistance Publique - Hôpitaux de Paris
Contact Adrien BEN HAMOU, MD-PhD
Phone 01 84 82 77 59
Email adrien.benhamou@hotmail.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 180
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

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)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Ultrasound description of the nodule: size (length x width x thickness) Day of the Fine Needle Aspiration Biopsy
Secondary Ultrasound description of the nodule: volume (length x width x thickness) Day of the Fine Needle Aspiration Biopsy
Secondary Ultrasound description of the nodule: echogenicity, as compared with the adjacent thyroid and muscular tissues Day of the Fine Needle Aspiration Biopsy
Secondary 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
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