Percutaneous Radiofrequency Thermal Ablation in Compressive Thyroid Nodules

Thyroid Nodule Clinical Trial

Official title:

Thyroid Nodules Treated With Percutaneous Radiofrequency Thermal Ablation: a Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01649206
• Other study ID #: RTA-2012
• Status: Completed
• Phase: Phase 3
• First received: July 16, 2012
• Last updated: July 25, 2012
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: July 2012
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Percutaneous radiofrequency thermal ablation (RTA) was reported as an effective tool for the management of thyroid nodules (TNs). This study aims to validate RTA as a valid approach for patients with compressive TNs for whom surgery is contraindicated or refused. Two groups of subjects with TNs (one group to treat with RTA and a matched untreated control group) will be evaluated in term of TN volume, thyroid hormones and clinical symptoms.

Description:

Thyroid nodules (TNs) are very common in the general population, with a prevalence of about 50% in subjects older than 60 years undergoing neck ultrasound examination.

The great majority of TNs are benign, but they can be responsible for pressure symptoms in the neck and result in discomfort and decreased quality of life. Large compressive TNs may result in life-threatening conditions because of the potential acute onset of respiratory crisis. Percutaneous radiofrequency thermal ablation (RTA) is a minimally invasive procedure which has been firstly develop to treat patients with liver cancer and has been then used to treat both malignant and benign tumor nodules in many organs. RTA also represents a promising new approach for the management of TNs.The current prospective comparative study investigated the long-term effectiveness of RTA in patients with both toxic and non-toxic compressive TNs.

Forty consecutive patients with TNs with pressure symptoms were prospectively enrolled in this study. Patients were randomised as follows: 20 patients were treated with a single RTA session (group A) and 20 patients did not receive any treatment and were only followed-up (group B).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 87 Years

Eligibility

Inclusion Criteria:

• age > 18 years;

• benign thyroid nodules (TYR 2)

• solid or predominantly solid (colloid component < 30%) large (> 4.0 mL) thyroid nodules

• refusal and/or inefficacy of surgery and/or radioiodine therapy.

Exclusion Criteria:

• pregnancy

• malignant or suspicious thyroid nodules.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Intervention

Procedure:
• Percutaneous Radiofrequency Thermal Ablation
Percutaneous Radiofrequency Thermal Ablation (RTA) by using a RITA© StarBurst Talon needle (RITA Medical Systems, Fremont, CA). RTA is performed in each patient at Time 0.

Locations

Country	Name	City	State
Italy	"Federico II" University of Naples, Department of Clinical and Molecular Endocrinology and Oncology	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in TN volume	Evaluation of TN volume by using Ultrasonography.	12 months	No
Secondary	Efficacy on TN-related neck symptoms	Evaluation of TN-related neck symptoms scored separately as follows: 0 (absent), 1 (moderate), and 2 (severe). The sum of the individual scores generates a final score (SYS score) ranging from 0 to 6.	From time to treatment until 12 months. Time point evaluations at 1, 3, 6, 12 months.	No
Secondary	Efficacy on TN hyperfunction	Evaluation of TN hyperfunction by measuring serum concentrations of TSH, free thyroxine (fT4), free triiodothyronine (fT3) in patients with toxic TNs.	Efficacy on TN-related neck symptoms Time Frame: (FDAAA) From time to treatment until 12 months. Time point evaluations at 1, 3, 6, 12 months.	No
Secondary	Safety	Assessment of local impairment (pain, oedema, skin damage). Assessment of thyroid dysfunction by measuring serum concentrations of fT3, fT4, TSH.; Assessment of thyroid autoimmunity (anti-Thyroglobulin and anti-Thyroperoxidase antibodies).	At 1, 3, 6, 12 months after baseline.	Yes
Secondary	Change from baseline in TN volume	Evaluation of TN volume by using Ultrasonography	1 month	No
Secondary	Change from baseline in TN volume	Evaluation of TN volume by using Ultrasonography	3 months	No
Secondary	Change from baseline in TN volume	Evaluation of TN volume by using Ultrasonography	6 months	No