Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05726981

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

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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
  • Have a benign thyroid nodule treated by radiofrequency thermal ablation about 36 months (plus or minus 12 months) ago, regardless of nodule size changes
  • Able to provide written informed consent
  • Affiliated with a social security system (excluding AME)
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Previous use of alcohol for treatment
  • Taking anti-vitamin K anticoagulants
  • Taking 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
  • Adults under legal protection (guardianship or curatorship)
  • Persons unable to provide consent
  • Persons under any legal protection measure without exceptions

AI-Screening

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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

CONTACT

C

Camille BUFFET, MD-PhD

CONTACT

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