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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

July 16, 2012
July 25, 2012
January 2010
January 2011   (final data collection date for primary outcome measure)
Change from baseline in TN volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Evaluation of TN volume by using Ultrasonography.
Same as current
Complete list of historical versions of study NCT01649206 on ClinicalTrials.gov Archive Site
  • 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
  • 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).

Not Provided
Not Provided
 
Percutaneous Radiofrequency Thermal Ablation in Compressive Thyroid Nodules
Thyroid Nodules Treated With Percutaneous Radiofrequency Thermal Ablation: a Comparative Study

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Thyroid Nodule
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.
  • Experimental: Group A: RTA
    Percutaneous Radiofrequency Thermal Ablation (RTA).
    Intervention: Procedure: Percutaneous Radiofrequency Thermal Ablation
  • No Intervention: Group B: untreated
    No treatment, only follow-up
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 87 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01649206
RTA-2012
Yes
Annamaria Colao, Federico II University
Federico II University
Not Provided
Principal Investigator: Annamaria Colao "Federico II" University of Naples
Federico II University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP