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Cryoablation and RFA of Benign Thyroid Nodules: Pilot Study

Primary Purpose

Benign Thyroid Nodule

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
cryoablation
radiofrequency ablation
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Thyroid Nodule

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 years of age or older Patients with solitary or dominant 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 No thyroid autoimmune signs on ultrasound or by autoantibody levels above 100% of the standard levels Exclusion Criteria: Age under 18 years Extensive goiter Predominantly cystic nodule with small solid remnant (less than 10%) Hyperfunctioning nodules (confirmed by scintigraphy) Nodule volume > 65 cc TSH levels above the normal range Auto-immune treatment / thyroiditis 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

Sites / Locations

  • University of Sao Paulo General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cryoablation

Radiofrequency

Arm Description

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;

Single session with an RF device; an antenna will be used for the treatments; 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;

Outcomes

Primary Outcome Measures

evaluation of technical feasibility
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
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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 22, 2023
Last Updated
August 28, 2023
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06014229
Brief Title
Cryoablation and RFA of Benign Thyroid Nodules: Pilot Study
Official Title
Thermal Ablation of Benign Thyroid Nodules With Cryoablation or Radiofrequency
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the clinical response and safety of ultrasound guided percutaneous cryoablation and a radiofrequency ablation in the treatment of benign thyroid nodules as an alternative to the surgery. Ablation of benign thyroid nodules with cryoablation will be directed to patients with 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. The cryoablation or RFA will be directed 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). In our country, several radiofrequency thermal ablation (RFA) devices are available for use in the treatment of benign thyroid nodules, although some ablation devices do not have the manufacturer's registration for this purpose. Additionally, 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. Additionally, the same evaluation is possible using an RFA device not yet tested for this purpose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Thyroid Nodule

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pilot study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cryoablation
Arm Type
Experimental
Arm Description
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;
Arm Title
Radiofrequency
Arm Type
Experimental
Arm Description
Single session with an RF device; an antenna will be used for the treatments; 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;
Intervention Type
Device
Intervention Name(s)
cryoablation
Intervention Description
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;
Intervention Type
Device
Intervention Name(s)
radiofrequency ablation
Intervention Description
Single session with a radio frequency ablation device; an specific applicator will be used for the treatments; high impedance rates for RFA with moving-shot technique; 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;
Primary Outcome Measure Information:
Title
evaluation of technical feasibility
Description
Defined as the ability to puncture the nodule and perform the ablation as preoperatively planned.
Time Frame
immediately after ablation
Title
2) Incidence of adverse events secondary to the treatment (safety and tolerability) of thermal ablation of benign thyroid nodules
Description
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.
Time Frame
up to 4 weeks after ablation
Secondary Outcome Measure Information:
Title
Evaluation of technical success
Description
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.
Time Frame
ultrasound examinations 1, 3, 6 and 12 months after ablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Patients with solitary or dominant 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 No thyroid autoimmune signs on ultrasound or by autoantibody levels above 100% of the standard levels Exclusion Criteria: Age under 18 years Extensive goiter Predominantly cystic nodule with small solid remnant (less than 10%) Hyperfunctioning nodules (confirmed by scintigraphy) Nodule volume > 65 cc TSH levels above the normal range Auto-immune treatment / thyroiditis 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Freitas
Phone
55 11 2661-7861
Email
ricardo.freitas@hc.fm.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Sakamoto
Phone
55 11 2661-7861
Email
denise.sakamoto@hc.fm.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Freitas, MD, PhD
Organizational Affiliation
Instituto de Radiologia - Hospital das Clínicas da Universidade de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Sakamoto
Phone
55 11 2661 7861
Email
denise.sakamoto@hc.fm.usp.br

12. IPD Sharing Statement

Plan to Share IPD
No

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Cryoablation and RFA of Benign Thyroid Nodules: Pilot Study

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