Cryoablation of Benign Thyroid Nodules: a Pilot Study

NCT06014229 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 5.712.194
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Benign Thyroid Nodule

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Evaluation of technical success

  ultrasound examinations 1, 3, 6 and 12 months after ablation

Study Arms (1)

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;

Device: cryoablation

Interventions

cryoablation DEVICE

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;

Cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Interventions

Cryosurgery

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Ricardo Freitas, MD, PhD

  Instituto de Radiologia - Hospital das Clínicas da Universidade de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pilot study

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: August 24, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 1, 2025
• Last Updated: January 8, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)