Percutaneous Radiofrequency Thermal Ablation in Compressive Thyroid Nodules

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Annamaria Colao, Federico II University
ClinicalTrials.gov Identifier:
NCT01649206
First received: July 16, 2012
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Thyroid Nodule
Procedure: Percutaneous Radiofrequency Thermal Ablation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thyroid Nodules Treated With Percutaneous Radiofrequency Thermal Ablation: a Comparative Study

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Change from baseline in TN volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluation of TN volume by using Ultrasonography.


Secondary Outcome Measures:
  • Efficacy on TN-related neck symptoms [ Time Frame: From time to treatment until 12 months. Time point evaluations at 1, 3, 6, 12 months. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    Evaluation of TN hyperfunction by measuring serum concentrations of TSH, free thyroxine (fT4), free triiodothyronine (fT3) in patients with toxic TNs.

  • Safety [ Time Frame: At 1, 3, 6, 12 months after baseline. ] [ Designated as safety issue: Yes ]

    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).


  • Change from baseline in TN volume [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Evaluation of TN volume by using Ultrasonography

  • Change from baseline in TN volume [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Evaluation of TN volume by using Ultrasonography

  • Change from baseline in TN volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluation of TN volume by using Ultrasonography


Enrollment: 40
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A: RTA
Percutaneous Radiofrequency Thermal Ablation (RTA).
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.
No Intervention: Group B: untreated
No treatment, only follow-up

Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years to 87 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649206

Locations
Italy
"Federico II" University of Naples, Department of Clinical and Molecular Endocrinology and Oncology
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Investigators
Principal Investigator: Annamaria Colao "Federico II" University of Naples
  More Information

No publications provided

Responsible Party: Annamaria Colao, Department of Clinical and Molecular Endocrinology and Oncology, Federico II University
ClinicalTrials.gov Identifier: NCT01649206     History of Changes
Other Study ID Numbers: RTA-2012
Study First Received: July 16, 2012
Last Updated: July 25, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Federico II University:
Thyroid Nodule
Radiofrequency Thermal Ablation
Pressure symptoms
Hyperthyroidism

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Nodule
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on July 31, 2014