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Completed

NCT Number: NCT01649206

Percutaneous Radiofrequency Thermal Ablation in Compressive Thyroid Nodules

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.

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Key information

Age range

18 year–87 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

"Federico II" University of Naples, Department of Clinical and Molecular Endocrinology and Oncology

Naples, 80131, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Percutaneous Radiofrequency Thermal Ablation

Procedure

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.

Primary outcomes

  1. Change from baseline in TN volume

    Time frame: 12 months

    Evaluation of TN volume by using Ultrasonography.

Secondary outcomes

  1. Efficacy on TN-related neck symptoms

    Time frame: From time to treatment until 12 months. Time point evaluations at 1, 3, 6, 12 months.

    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.

  2. Efficacy on TN hyperfunction

    Time frame: 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.

    Evaluation of TN hyperfunction by measuring serum concentrations of TSH, free thyroxine (fT4), free triiodothyronine (fT3) in patients with toxic TNs.

  3. Safety

    Time frame: At 1, 3, 6, 12 months after baseline.

    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).

  4. Change from baseline in TN volume

    Time frame: 1 month

    Evaluation of TN volume by using Ultrasonography

  5. Change from baseline in TN volume

    Time frame: 3 months

    Evaluation of TN volume by using Ultrasonography

  6. Change from baseline in TN volume

    Time frame: 6 months

    Evaluation of TN volume by using Ultrasonography

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 25, 2012
Registry last updated
Jul 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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