Thyroid NodulePhase 3NCT01649206
Percutaneous Radiofrequency Thermal Ablation in Compressive Thyroid Nodules
A Phase 3 study testing Percutaneous Radiofrequency Thermal Ablation in people with Thyroid Nodule, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 87 years
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- Percutaneous Radiofrequency Thermal Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Jun 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 87 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- pregnancy
- malignant or suspicious thyroid nodules.
Trial locations and contacts
1 site in 1 country.
Italy1 site
"Federico II" University of Naples, Department of Clinical and Molecular Endocrinology and Oncology
Naples, 80131
About this study
Official title: 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.
Read the 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).
- Conditions
- Thyroid Nodule
- Being tested
- Percutaneous Radiofrequency Thermal Ablation
- Keywords
- Thyroid Nodule, Radiofrequency Thermal Ablation, Pressure symptoms, Hyperthyroidism
- Medical subject headings
- Thyroid Nodule, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Radiofrequency Thermal AblationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: RTA | Experimental | Percutaneous Radiofrequency Thermal Ablation (RTA). Receives: Procedure: Percutaneous Radiofrequency Thermal Ablation |
| Group B: untreated | No intervention | No treatment, only follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in TN volume
Evaluation of TN volume by using Ultrasonography.
Measured: 12 months
Secondary outcomes (6)
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.
Measured: From time to treatment until 12 months. Time point evaluations at 1, 3, 6, 12 months.
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.
Measured: 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
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).
Measured: At 1, 3, 6, 12 months after baseline.
Change from baseline in TN volume
Evaluation of TN volume by using Ultrasonography
Measured: 1 month
Change from baseline in TN volume
Evaluation of TN volume by using Ultrasonography
Measured: 3 months
Change from baseline in TN volume
Evaluation of TN volume by using Ultrasonography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annamaria Colao, Federico II University
- Investigators
- Annamaria Colao, Principal investigator, "Federico II" University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649206
- Sponsor's protocol ID
- RTA-2012
- Status last verified
- Jul 2012
- First submitted
- 16 Jul 2012
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Nodules Treated With Percutaneous Radiofrequency Thermal Ablation: a Comparative Study
- ClinicalTrials.gov ID
- NCT01649206
- Acronym / sponsor ID
- RTA-2012
- Conditions
- Thyroid Nodule
- Keywords
- Thyroid Nodule, Radiofrequency Thermal Ablation, Pressure symptoms, Hyperthyroidism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 25 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: RTA | Experimental | Procedure: Percutaneous Radiofrequency Thermal AblationPercutaneous Radiofrequency Thermal Ablation (RTA). |
| Group B: untreated | No intervention | –No treatment, only follow-up |
Who may qualify
- Ages
- 18 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- pregnancy
- malignant or suspicious thyroid nodules.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Radiofrequency Thermal AblationPercutaneous 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. | Procedure or surgery | Group A: RTA |
Primary outcome
Change from baseline in TN volume
Time frame: 12 months
Evaluation of TN volume by using Ultrasonography.
6 secondary outcomes
Efficacy on TN-related neck symptoms
Time frame: From time to treatment until 12 months. Time point evaluations at 1, 3, 6, 12 months.
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.
Safety
Time frame: At 1, 3, 6, 12 months after baseline.
Change from baseline in TN volume
Time frame: 1 month
Change from baseline in TN volume
Time frame: 3 months
Change from baseline in TN volume
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annamaria Colao principal investigator
"Federico II" University of Naples
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Percutaneous Radiofrequency Thermal Ablation in people with Thyroid Nodule, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in TN volume (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2012.