Cryoablation of Benign Thyroid Nodules: a Pilot Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Benign Thyroid Nodule
• Intervention / Treatment: Device: cryoablation

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • University of Sao Paulo General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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;
• Malignant or suspected malignant cytologic specimens;
• Pregnancy or breast-feeding;
• Anaplastic or poor-differentiated thyroid carcinoma;
• Partial thyroidectomy
• Asymptomatic patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cryoablation; 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;

Device: cryoablation; 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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of technical feasibility	Defined as the ability to puncture the nodule and perform the ablation as preoperatively planned.	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.	up to 4 weeks after ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	ultrasound examinations 1, 3, 6 and 12 months after ablation

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Ricardo Freitas, MD, PhD, Instituto de Radiologia - Hospital das Clínicas da Universidade de São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2023
• Primary Completion (Actual): November 30, 2024
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: 5.712.194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes