Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05726981

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-03

180

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are examining benign thyroid nodules that have been treated with radiofrequency thermal ablation about three years ago. The study aims to understand the ultrasound and cytological changes in these nodules, as current tools like the EU-TIRADS classification are not validated for nodules treated by thermal ablation. This research will help develop a specific ultrasound risk classification and a cytological atlas based on the Bethesda 2017 classification for these treated nodules. The study involves patients who underwent thermal ablation for benign thyroid nodules at least 36 months prior. These patients receive systematic evaluations including neck ultrasound and fine needle aspiration biopsy (FNAB), a minimally invasive procedure using very fine needles performed by experienced sonographers. The research will gather detailed ultrasound data on nodule size, volume, echogenicity, and echostructure, along with cytological assessments. Participants attend clinical and ultrasound monitoring as part of their follow-up. On the biopsy day, researchers assess changes in nodule cells according to the Bethesda classification and describe ultrasound features like size and composition. The study focuses on monitoring these nodules three years after treatment, with patients monitored annually by the Thyroid Disease and Endocrine Tumor Department. This ongoing evaluation helps to track the nodules’ behavior and potential changes over time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients older than 18 years
  • Carrier of a benign thyroid nodule treated by radiofrequency thermal ablation 36 months plus or minus 12 months
  • Nodules may be stable, increasing, or decreasing in size during screening or on inclusion day
  • Written informed consent must be obtained
  • Affiliation to a social security system (excluding AME)
Not Eligible

You will not qualify if you...

  • 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 reasons other than research
  • Persons under legal protection (guardianship or curatorship)
  • Persons unable to express consent
  • Persons under a legal protection measure without derogation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Ultrasound and Fine Needle Aspiration Biopsy Evaluation

Duration - 1 day

Participants undergo ultrasound and fine needle aspiration biopsy (FNAB) to evaluate the thyroid nodule three years after radiofrequency thermal ablation.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 3 years

Participants receive annual clinical and ultrasound monitoring as part of ongoing follow-up in the thyroid disease department.

Annual visits for up to 3 years

Trial Site Locations

Total: 1 location

1

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

Paris, France, 75651

Actively Recruiting

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Research Team

A

Adrien BEN HAMOU, MD-PhD

C

Camille BUFFET, MD-PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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