3-year ultrasound and fine-needle biopsy check after radiofrequency ablation of benign thyroid nodules

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

This project will test whether a neck ultrasound and a fine-needle biopsy three years after radiofrequency ablation can help spot suspicious changes or recurrence in adults treated for benign thyroid nodules.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Paris)
• Trial ID: NCT05726981 on ClinicalTrials.gov

What this trial studies

This is a prospective exploratory cohort of approximately 180 treated nodules undergoing a systematic neck ultrasound and fine-needle aspiration biopsy around 36 months after radiofrequency thermal ablation. The study will record ultrasound features and cytology using the 2017 Bethesda classification to build an atlas of post-ablation appearances. Because EU-TIRADS is not validated for nodules that have undergone thermal ablation, the protocol aims to describe ultrasound criteria specific to post-ablation nodules and correlate them with cytology. The work is conducted at the Department of Thyroid and Endocrine Tumour Pathologies, Hospital Pitié-Salpêtrière (AP-HP) in Paris.

Who should consider this trial

Good fit: Adults (over 18) who had a previously benign thyroid nodule treated with radiofrequency thermal ablation about 36 months (±12 months) earlier, can give informed consent, and are eligible under the study's exclusion rules (for example not pregnant and not on anticoagulants).

Not a fit: Patients who are pregnant or breastfeeding, recently treated with other ablation methods (alcohol), on anticoagulant therapy, unable to consent, or who had RFA outside the 36±12 month window are unlikely to be eligible or to receive direct benefit from this protocol.

Why it matters

Potential benefit: If successful, this could help doctors know which post-ablation nodules need biopsy or follow-up and improve early detection of malignancy while avoiding unnecessary procedures.

How similar studies have performed: This approach is largely novel because there is limited published cytological data on nodules after thermal ablation, so the protocol is exploratory rather than building on established post-ablation cytology guidelines.

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 +/- 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)

Where this trial is running

Paris

• Hospital Pitié-Salpêtrière - Department of Thyroid and Endocrine Tumour Pathologies — Paris, France (Recruiting)

Study contacts

• Study coordinator: Adrien BEN HAMOU, MD-PhD

Conditions Thermal Ablation; Fine Needle Aspiration Biopsy; Thyroid Nodules