Thyroid NoduleNCT05765695
Radiofrequency Ablation in TIR3A Nodules With Negative Genetic Evaluation
A study testing Radiofrequency ablation performed with a 19 gauge STARmed needle. in people with Thyroid Nodule, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
The goal of this clinical trial is to demonstrate that TIR3A nodules with negative genetic test can be safely and effectively treated by radiofrequency ablation, with nodular shrinkage and improvement of clinical symptoms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- Radiofrequency ablation performed with a 19 gauge STARmed needle.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2021to 10 Jan 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with thyroid nodule eligible for radiofrequency ablation, with low-risk indeterminate lesion cytology (TIR3A) and negative genetic test for mutations associated with thyroid carcinoma
Who cannot join
- Patients who are not able to sign the informed consent
- Patients with contraindications to radiofrequency ablation
- Patients with cytology different from TIR3A
- Patients with positive genetic test for mutations associated with thyroid carcinoma
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano IRCCS
Milan, 20149
Laura Fugazzola, +390261911 ext. 2727, l.fugazzola@auxologico.it
About this study
Official title: Radiofrequency Ablation for Treating Thyroid Nodules Classified as TIR3A, With a Negative Genetic Evaluation for Thyroid Carcinoma
The goal of this clinical trial is to demonstrate that TIR3A nodules with negative genetic test can be safely and effectively treated by radiofrequency ablation, with nodular shrinkage and improvement of clinical symptoms.
Fine needle aspiration cytology is the gold standard test for differential diagnosis of thyroid nodules, but sometimes the result can be indeterminate with a risk of malignancy of 10-30%. In these cases the ablation is not indicated and many patients with benign nodules that may benefit from the procedure are not treated.
All the patients enrolled must have a TIR3A cytology and negative genetic test for mutations associated with thyroid carcinoma. Before the ablation blood, evaluation of serum TSH, anti-thyroglobulin antibodies, anti-thyroid peroxidase antibodies and calcitonin levels will be performed.
- Conditions
- Thyroid Nodule
- Being tested
- Radiofrequency ablation performed with a 19 gauge STARmed needle.
- Keywords
- thyroid nodule, indeterminate, genetic, radiofrequency ablation, follow-up
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation performed with a 19 gauge STARmed needle.Procedure or surgery
The ablation with radiofrequency is a safe and effective minimally invasive procedure that results in thermal tissue necrosis. A needle electrode is inserted into the thyroid nodule using ultrasound guidance and generates heat by alternating electric current causing thermal injury. Afterwards, the ablated tissue is gradually absorbed with progressive shrinkage of the nodule.
| Study group | Role | What they receive |
|---|---|---|
| Treated group | Experimental | Not described Receives: Procedure: Radiofrequency ablation performed with a 19 gauge STARmed needle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid nodule volume reduction rate
The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
Measured: 1 month after the procedure
Thyroid nodule volume reduction rate
The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
Measured: 6 months after the procedure
Thyroid nodule volume reduction rate
The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
Measured: 12 months after the procedure
Complication rate
Assessment of the complications of the procedure and over time
Measured: When the procedure is performed
Complication rate
Assessment of the complications of the procedure and over time
Measured: 1 month after the procedure
Complication rate
Assessment of the complications of the procedure and over time
Measured: 6 months after the procedure
Complication rate
Assessment of the complications of the procedure and over time
Measured: 12 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start10 Jan 2021
- Primary completion10 Jan 2025 (estimated)
- Study completion10 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765695
- Sponsor's protocol ID
- 05C023
- Status last verified
- Apr 2024
- First submitted
- 27 Feb 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation for Treating Thyroid Nodules Classified as TIR3A, With a Negative Genetic Evaluation for Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT05765695
- Acronym / sponsor ID
- 05C023
- Conditions
- Thyroid Nodule
- Keywords
- thyroid nodule, indeterminate, genetic, radiofrequency ablation, follow-up
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 13 Mar 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.
The goal of this clinical trial is to demonstrate that TIR3A nodules with negative genetic test can be safely and effectively treated by radiofrequency ablation, with nodular shrinkage and improvement of clinical symptoms.
Fine needle aspiration cytology is the gold standard test for differential diagnosis of thyroid nodules, but sometimes the result can be indeterminate with a risk of malignancy of 10-30%. In these cases the ablation is not indicated and many patients with benign nodules that may benefit from the procedure are not treated.
All the patients enrolled must have a TIR3A cytology and negative genetic test for mutations associated with thyroid carcinoma. Before the ablation blood, evaluation of serum TSH, anti-thyroglobulin antibodies, anti-thyroid peroxidase antibodies and calcitonin levels will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated group | Experimental | Procedure: Radiofrequency ablation performed with a 19 gauge STARmed needle. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with thyroid nodule eligible for radiofrequency ablation, with low-risk indeterminate lesion cytology (TIR3A) and negative genetic test for mutations associated with thyroid carcinoma
Key exclusion criteria (4 listed)
- Patients who are not able to sign the informed consent
- Patients with contraindications to radiofrequency ablation
- Patients with cytology different from TIR3A
- Patients with positive genetic test for mutations associated with thyroid carcinoma
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 |
|---|---|---|
| Radiofrequency ablation performed with a 19 gauge STARmed needle.The ablation with radiofrequency is a safe and effective minimally invasive procedure that results in thermal tissue necrosis. A needle electrode is inserted into the thyroid nodule using ultrasound guidance and generates heat by alternating electric current causing thermal injury. Afterwards, the ablated tissue is gradually absorbed with progressive shrinkage of the nodule. | Procedure or surgery | Treated group |
Primary outcome
Thyroid nodule volume reduction rate
Time frame: 1 month after the procedure
The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
Thyroid nodule volume reduction rate
Time frame: 6 months after the procedure
The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
Thyroid nodule volume reduction rate
Time frame: 12 months after the procedure
The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
Complication rate
Time frame: When the procedure is performed
Assessment of the complications of the procedure and over time
Complication rate
Time frame: 1 month after the procedure
Assessment of the complications of the procedure and over time
Complication rate
Time frame: 6 months after the procedure
Assessment of the complications of the procedure and over time
Complication rate
Time frame: 12 months after the procedure
Assessment of the complications of the procedure and over time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation performed with a 19 gauge STARmed needle. in people with Thyroid Nodule, run by Istituto Auxologico Italiano at 1 site in Italy.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Fugazzola (+390261911 ext. 2727, l.fugazzola@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid nodule volume reduction rate (time frame: 1 month after the procedure). The study lists 7 primary outcomes in all. 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 16 Apr 2024.