Thermal AblationCYTOTHYRAFNCT05726981
Ultrasound and Cytological Evaluation 3 Years After Radiofrequency Thermal Ablation of Benign Thyroid Nodules : a Prospective Exploratory Cohort of 180 Nodules
A study testing Fine needle aspiration biopsy (FNAB) in people with Thermal Ablation and Fine Needle Aspiration Biopsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thermal Ablation, Fine Needle Aspiration Biopsy, Thyroid Nodules
- What is being tested?
- Fine needle aspiration biopsy (FNAB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2023to 29 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 years old
- 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.
- Obtaining written informed consent
- Affiliation to a social security system (excluding AME)
Who cannot join
- 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
Show all 10Show fewer
- Persons admitted to a health or social institution for purposes other than research
- Persons of full age who are under legal protection (guardianship or curatorship)
- Persons unable to express their consent
- Persons under a legal protection measure (there can be no derogation for this category)
Trial locations and contacts
1 site in 1 country.
France1 site
Hospital Pitié-Salpêtrière - Department of Thyroid and Endocrine Tumour Pathologies
Paris, 75651
About this study
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.
- Being tested
- Fine needle aspiration biopsy (FNAB)
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine needle aspiration biopsy (FNAB)Procedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Patients with nodules treated by thermal ablation | Experimental | The study population is a monocentric cohort of patients who underwent thermoablation treatment for benign thyroid nodules 3 years ago. These patients aged >18 years-old were carriers of a benign but troublesome thyroid nodule before thermal ablation, either unique or "dominant", i.e. associated with one or more other non-significant nodules (<20 mm) that were subjected to simple ultrasound surveillance. Patients refused, after clear and fair information, surgical management of their nodule. On average, 2 patients have been treated for TA per week in the Thyroid Disease and Endocrine Tumor Department since 2016. Patients systematically benefit from annual clinical and ultrasound monitoring as part of their follow-up in our Department. Receives: Procedure: Fine needle aspiration biopsy (FNAB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of the Fine Needle Aspiration Biopsy
Secondary outcomes (4)
Ultrasound description of the nodule: size (length x width x thickness)
Measured: Day of the Fine Needle Aspiration Biopsy
Ultrasound description of the nodule: volume (length x width x thickness)
Measured: Day of the Fine Needle Aspiration Biopsy
Ultrasound description of the nodule: echogenicity, as compared with the adjacent thyroid and muscular tissues
Measured: Day of the Fine Needle Aspiration Biopsy
Ultrasound description of the nodule: echostructure, measured as the percentage of liquid volume compared to nodule's total volume
Measured: Day of the Fine Needle Aspiration Biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start29 Jun 2023
- Primary completion8 Jan 2026
- Study completion29 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thermal AblationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726981
- Sponsor's protocol ID
- APHP211436
- Acronym
- CYTOTHYRAF
- Status last verified
- Aug 2026
- First submitted
- 12 Jan 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound and Cytological Evaluation 3 Years After Radiofrequency Thermal Ablation of Benign Thyroid Nodules : a Prospective Exploratory Cohort of 180 Nodules
- ClinicalTrials.gov ID
- NCT05726981
- Acronym / sponsor ID
- CYTOTHYRAF / APHP211436
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with nodules treated by thermal ablation | Experimental | Procedure: Fine needle aspiration biopsy (FNAB)The study population is a monocentric cohort of patients who underwent thermoablation treatment for benign thyroid nodules 3 years ago. These patients aged >18 years-old were carriers of a benign but troublesome thyroid nodule before thermal ablation, either unique or "dominant", i.e. associated with one or more other non-significant nodules (<20 mm) that were subjected to simple ultrasound surveillance. Patients refused, after clear and fair information, surgical management of their nodule. On average, 2 patients have been treated for TA per week in the Thyroid Disease and Endocrine Tumor Department since 2016. Patients systematically benefit from annual clinical and ultrasound monitoring as part of their follow-up in our Department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients > 18 years old
- 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.
- Obtaining written informed consent
- Affiliation to a social security system (excluding AME)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Procedure or surgery | Patients with nodules treated by thermal ablation |
Primary outcome
Cytological change after thermoablation, as described by the 2017 Bethesda classification in six classes, scale ranging from I to VI.
Time frame: Day of the Fine Needle Aspiration Biopsy
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.
4 secondary outcomes
Ultrasound description of the nodule: size (length x width x thickness)
Time frame: Day of the Fine Needle Aspiration Biopsy
Ultrasound description of the nodule: volume (length x width x thickness)
Time frame: Day of the Fine Needle Aspiration Biopsy
Ultrasound description of the nodule: echogenicity, as compared with the adjacent thyroid and muscular tissues
Time frame: Day of the Fine Needle Aspiration Biopsy
Ultrasound description of the nodule: echostructure, measured as the percentage of liquid volume compared to nodule's total volume
Time frame: Day of the Fine Needle Aspiration Biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Thermal Ablation
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Recruiting
Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
Active, not recruiting
Examinations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome
Liver Cancer
Recruiting
Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda
HIV (Human Immunodeficiency Virus), HPV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fine needle aspiration biopsy (FNAB) in people with Thermal Ablation and Fine Needle Aspiration Biopsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytological change after thermoablation, as described by the 2017 Bethesda classification in six classes, scale ranging from I to VI. (time frame: Day of the Fine Needle Aspiration Biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.