Benign Thyroid NoduleNCT06014229
Cryoablation of Benign Thyroid Nodules: a Pilot Study
A study testing cryoablation in people with Benign Thyroid Nodule, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This study will evaluate the clinical response and safety of ultrasound guided percutaneous cryoablation in the treatment of benign thyroid nodules as an alternative to the surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Thyroid Nodule
- What is being tested?
- cryoablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 24 Aug 2023to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years of age or older
- Patients with solitary or dominant functioning or non-functioning thyroid nodules with two consecutive fine needle aspiration biopsy (FNAb)-proven benign in the last 12 months
- Thyroid nodules should be solid or almost solid (less than 40% of liquid component) with volume between 5 and 65 cc;
- Patients considered high surgical risk candidates or patients are eligible to surgery who are informed about the ablation therapy and prefers it instead surgery;
- Calcitonin, thyroglobulin or TSH serum levels in the normal range values
Who cannot join
- Age under 18 years
- Extensive goiter
- Predominantly cystic nodule with small solid remnant (less than 10%)
- Nodule volume > 65 cc
- TSH levels above the normal range
- Uncorrectable coagulopathy / impossibility to interrupt anticoagulants;
Show all 11Show fewer
- Malignant or suspected malignant cytologic specimens;
- Pregnancy or breast-feeding;
- Anaplastic or poor-differentiated thyroid carcinoma;
- Partial thyroidectomy
- Asymptomatic patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thermal Ablation of Benign Thyroid Nodules with Cryoablation
This study will evaluate the clinical response and safety of ultrasound guided percutaneous cryoablation in the treatment of benign thyroid nodules as an alternative to the surgery. Ablation of functioning or non-functioning benign thyroid nodules with cryoablation will be directed to patients with symptomatic benign thyroid lesions (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component; patients must present with serum free thyroxine (T4) and thyroid stimulating hormone (TSH) between the normal range values, with no signs of thyroiditis by serum antibodies over 100% of the standard values; calcitonin levels in the normal range values. Cryoablation will be directed to patients in a non-randomized fashion. Clinical, laboratorial and imaging monitoring will be performed in 12 months, including contrast-enhanced ultrasound when indicated, by 1, 3, 6 and 12 months.
Read the detailed description
Palpable nodular thyroid disease is common in up to 6.4% of the population, and it becomes more common when the thyroid is examined by ultrasound. The vast majority of nodules are benign and, over time, do not change considerably in size. The main treatment indications for a euthyroid patient with a benign thyroid nodule that is not hyperfunctioning are compression of the trachea or esophagus, growth of the nodule, and recurrence of a cystic nodule after aspiration. Other indications for treatment are neck discomfort, cosmetic concern, and patient anxiety about the lump. The main therapeutic options are surgery (unilateral lobectomy) and treatment with thyroxine. Thermal ablative therapy has become a treatment option for solid thyroid lesions, with extensive reports in the medical literature on safety and efficacy with laser and radiofrequency devices, including long-term follow-up studies (10 years). There is no record in the medical literature of the use of cryoablation devices for the ablation of benign thyroid nodules, although they are used for the treatment of tumor lesions in different sites (hepatic, renal, pulmonary, bone and cervical lymph nodes).The objective of this research is to evaluate, in a pilot study, the safety and efficacy of cryoablation in the treatment of benign thyroid nodules.
- Conditions
- Benign Thyroid Nodule
- Being tested
- cryoablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryoablationDevice
Single session with an argon-based cryoablation device; an specific applicator will be used for the treatments; gas release 100% for cryoablation; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component;
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Experimental | Device: Cryoablation Single session with an argon-based device; a V-probe 17-G applicator will be used for the treatments; gas release 100%; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component; Receives: Device: cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of technical feasibility
Defined as the ability to puncture the nodule and perform the ablation as preoperatively planned.
Measured: immediately after ablation
2) Incidence of adverse events secondary to the treatment (safety and tolerability) of thermal ablation of benign thyroid nodules
Evaluation of minor and major complication rates, immediately after and 1 month after ablation [designed as a safety measure: yes]. The safety endpoint for this study is to evaluate the incidence and severity of the procedure or device-related adverse events, as reported by the CTCAE V5.2017.
Measured: up to 4 weeks after ablation
Secondary outcomes (1)
Evaluation of technical success
Technical success is defined as to achieve a nodular volume ablation of 50% at 12-month follow up compared to baseline. Nodule volume measurement is performed with the ellipsoid formula: length x width x depth x 0.524.
Measured: ultrasound examinations 1, 3, 6 and 12 months after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start24 Aug 2023
- Primary completion30 Nov 2024
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Thyroid NoduleStudies of the same condition, open and under way.
- 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
- Model description
- pilot study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Freitas, MD, PhD, Principal investigator, Instituto de Radiologia - Hospital das Clínicas da Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014229
- Sponsor's protocol ID
- 5.712.194
- Status last verified
- Oct 2024
- First submitted
- 22 Aug 2023
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Ablation of Benign Thyroid Nodules with Cryoablation
- ClinicalTrials.gov ID
- NCT06014229
- Acronym / sponsor ID
- 5.712.194
- Conditions
- Benign Thyroid Nodule
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 28 Aug 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.
This study will evaluate the clinical response and safety of ultrasound guided percutaneous cryoablation in the treatment of benign thyroid nodules as an alternative to the surgery. Ablation of functioning or non-functioning benign thyroid nodules with cryoablation will be directed to patients with symptomatic benign thyroid lesions (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component; patients must present with serum free thyroxine (T4) and thyroid stimulating hormone (TSH) between the normal range values, with no signs of thyroiditis by serum antibodies over 100% of the standard values; calcitonin levels in the normal range values. Cryoablation will be directed to patients in a non-randomized fashion. Clinical, laboratorial and imaging monitoring will be performed in 12 months, including contrast-enhanced ultrasound when indicated, by 1, 3, 6 and 12 months.
Detailed description
Palpable nodular thyroid disease is common in up to 6.4% of the population, and it becomes more common when the thyroid is examined by ultrasound. The vast majority of nodules are benign and, over time, do not change considerably in size. The main treatment indications for a euthyroid patient with a benign thyroid nodule that is not hyperfunctioning are compression of the trachea or esophagus, growth of the nodule, and recurrence of a cystic nodule after aspiration. Other indications for treatment are neck discomfort, cosmetic concern, and patient anxiety about the lump. The main therapeutic options are surgery (unilateral lobectomy) and treatment with thyroxine. Thermal ablative therapy has become a treatment option for solid thyroid lesions, with extensive reports in the medical literature on safety and efficacy with laser and radiofrequency devices, including long-term follow-up studies (10 years). There is no record in the medical literature of the use of cryoablation devices for the ablation of benign thyroid nodules, although they are used for the treatment of tumor lesions in different sites (hepatic, renal, pulmonary, bone and cervical lymph nodes).The objective of this research is to evaluate, in a pilot study, the safety and efficacy of cryoablation in the treatment of benign thyroid nodules.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pilot study
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Experimental | Device: cryoablationDevice: Cryoablation Single session with an argon-based device; a V-probe 17-G applicator will be used for the treatments; gas release 100%; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Patients with solitary or dominant functioning or non-functioning thyroid nodules with two consecutive fine needle aspiration biopsy (FNAb)-proven benign in the last 12 months
- Thyroid nodules should be solid or almost solid (less than 40% of liquid component) with volume between 5 and 65 cc;
- Patients considered high surgical risk candidates or patients are eligible to surgery who are informed about the ablation therapy and prefers it instead surgery;
- Calcitonin, thyroglobulin or TSH serum levels in the normal range values
Key exclusion criteria (11 listed)
- Age under 18 years
- Extensive goiter
- Predominantly cystic nodule with small solid remnant (less than 10%)
- Nodule volume > 65 cc
- TSH levels above the normal range
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 |
|---|---|---|
| cryoablationSingle session with an argon-based cryoablation device; an specific applicator will be used for the treatments; gas release 100% for cryoablation; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component; | Device | Cryoablation |
Primary outcome
evaluation of technical feasibility
Time frame: immediately after ablation
Defined as the ability to puncture the nodule and perform the ablation as preoperatively planned.
2) Incidence of adverse events secondary to the treatment (safety and tolerability) of thermal ablation of benign thyroid nodules
Time frame: up to 4 weeks after ablation
Evaluation of minor and major complication rates, immediately after and 1 month after ablation [designed as a safety measure: yes]. The safety endpoint for this study is to evaluate the incidence and severity of the procedure or device-related adverse events, as reported by the CTCAE V5.2017.
1 secondary outcome
Evaluation of technical success
Time frame: ultrasound examinations 1, 3, 6 and 12 months after ablation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Ricardo Freitas, MD, PhD principal investigator
Instituto de Radiologia - Hospital das Clínicas da Universidade de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryoablation in people with Benign Thyroid Nodule, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 5 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2025. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
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?
evaluation of technical feasibility (time frame: immediately after ablation). The study lists 2 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 8 Jan 2025.