Percutaneous Radiofrequency Thermal Ablation in Compressive Thyroid Nodules
Thyroid Nodules Treated With Percutaneous Radiofrequency Thermal Ablation: a Comparative Study
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 16, 2012
CompletedFirst Posted
Study publicly available on registry
July 25, 2012
CompletedJuly 26, 2012
July 1, 2012
1 year
July 16, 2012
July 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in TN volume
Evaluation of TN volume by using Ultrasonography.
12 months
Secondary Outcomes (6)
Efficacy on TN-related neck symptoms
From time to treatment until 12 months. Time point evaluations at 1, 3, 6, 12 months.
Efficacy on TN hyperfunction
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.
Safety
At 1, 3, 6, 12 months after baseline.
Change from baseline in TN volume
1 month
Change from baseline in TN volume
3 months
- +1 more secondary outcomes
Study Arms (2)
Group A: RTA
EXPERIMENTALPercutaneous Radiofrequency Thermal Ablation (RTA).
Group B: untreated
NO INTERVENTIONNo treatment, only follow-up
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- pregnancy
- malignant or suspicious thyroid nodules.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
"Federico II" University of Naples, Department of Clinical and Molecular Endocrinology and Oncology
Naples, 80131, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Annamaria Colao
"Federico II" University of Naples
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Clinical and Molecular Endocrinology and Oncology
Study Record Dates
First Submitted
July 16, 2012
First Posted
July 25, 2012
Study Start
January 1, 2010
Primary Completion
January 1, 2011
Study Completion
June 1, 2011
Last Updated
July 26, 2012
Record last verified: 2012-07