Percutaneous Radiofrequency Thermal Ablation in Compressive Thyroid Nodules
Primary Purpose
Thyroid Nodule
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Percutaneous Radiofrequency Thermal Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Nodule focused on measuring Thyroid Nodule, Radiofrequency Thermal Ablation, Pressure symptoms, Hyperthyroidism
Eligibility 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.
Sites / Locations
- "Federico II" University of Naples, Department of Clinical and Molecular Endocrinology and Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group A: RTA
Group B: untreated
Arm Description
Percutaneous Radiofrequency Thermal Ablation (RTA).
No treatment, only follow-up
Outcomes
Primary Outcome Measures
Change from baseline in TN volume
Evaluation of TN volume by using Ultrasonography.
Secondary Outcome Measures
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.
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.
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).
Change from baseline in TN volume
Evaluation of TN volume by using Ultrasonography
Change from baseline in TN volume
Evaluation of TN volume by using Ultrasonography
Change from baseline in TN volume
Evaluation of TN volume by using Ultrasonography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01649206
Brief Title
Percutaneous Radiofrequency Thermal Ablation in Compressive Thyroid Nodules
Official Title
Thyroid Nodules Treated With Percutaneous Radiofrequency Thermal Ablation: a Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule
Keywords
Thyroid Nodule, Radiofrequency Thermal Ablation, Pressure symptoms, Hyperthyroidism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: RTA
Arm Type
Experimental
Arm Description
Percutaneous Radiofrequency Thermal Ablation (RTA).
Arm Title
Group B: untreated
Arm Type
No Intervention
Arm Description
No treatment, only follow-up
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Radiofrequency Thermal Ablation
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline in TN volume
Description
Evaluation of TN volume by using Ultrasonography.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Efficacy on TN-related neck symptoms
Description
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.
Time Frame
From time to treatment until 12 months. Time point evaluations at 1, 3, 6, 12 months.
Title
Efficacy on TN hyperfunction
Description
Evaluation of TN hyperfunction by measuring serum concentrations of TSH, free thyroxine (fT4), free triiodothyronine (fT3) in patients with toxic TNs.
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.
Title
Safety
Description
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).
Time Frame
At 1, 3, 6, 12 months after baseline.
Title
Change from baseline in TN volume
Description
Evaluation of TN volume by using Ultrasonography
Time Frame
1 month
Title
Change from baseline in TN volume
Description
Evaluation of TN volume by using Ultrasonography
Time Frame
3 months
Title
Change from baseline in TN volume
Description
Evaluation of TN volume by using Ultrasonography
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
87 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annamaria Colao
Organizational Affiliation
"Federico II" University of Naples
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Federico II" University of Naples, Department of Clinical and Molecular Endocrinology and Oncology
City
Naples
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
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Percutaneous Radiofrequency Thermal Ablation in Compressive Thyroid Nodules
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