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| Name | Class |
|---|---|
| Hungarian Ministry of Innovation and Technology | UNKNOWN |
| Semmelweis University | OTHER |
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Researchers in this study aim to prove the safety and efficacy of radiofrequency ablation in the treatment of a carefully selected low-risk papillary thyroid microcarcinoma patient group.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation alone | Procedure | Ultrasound-guided percutaneous radiofrequency ablation of T1N0M0 papillary thyroid microcarcinomas |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients without clinical evidence of a tumor on ultrasound and cytology on the treatment site | We measure the number of patients without clinical evidence of a papillary thyroid microcarcinoma at the treatment site, evaluated with a (B-mode) ultrasound scan and a contrast-enhanced ultrasound scan of the whole tyroid and cytology reports from a fine needle aspiration from the site of the treatment at 24 months post-ablation. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse effects | Adverse effects measured during and after the procedure according to SIR AE | 24 months |
| Volume reduction ratio | Volume reduction ratio: The volume reduction (pre-ablation volume minus final volume) compared to the pre-ablation volume, times 100. Volumes are measured on ultrasound. Length, width and depth is determined using the longest diameters on 3 perpendicular planes. Volume is calculated using the ellipsoid volume formula: (length x width x depth) x π/6. |
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Inclusion Criteria:
Exclusion Criteria:
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All participants are of Hungarian nationality, treated and controlled in the PremierMed Center in Budapest with cytologically confirmed papillary thyroid microcarcinoma
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| Name | Affiliation | Role |
|---|---|---|
| Pál Á Deák, MD PhD associate professor | Semmelweis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Med Egészségügyi- Oktató- és Kutatóintézet | Budapest | 1037 | Hungary |
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| Label | URL |
|---|---|
| Patient Information Site by the Research Site | View source |
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| ID | Term |
|---|---|
| C563277 | Papillary Thyroid Microcarcinoma |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| 24 months |