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| Name | Class |
|---|---|
| RF Medical Co., Ltd | UNKNOWN |
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Traditionally, surgery has been the standard recommendation for treating papillary thyroid cancer. The risk of surgery including permanent hoarseness, permanent hypocalcemia, a mid-cervical scar, and the potential for permanent hypothyroidism may be unacceptable for some patients, especially with low risk papillary thyroid carcinoma. The recent American Thyroid Association guidelines have proposed the option of active surveillance with low risk papillary thyroid cancer less than 210 mm. However, most patients find observation anxiety provoking knowing of having cancer. Radiofrequency ablation (RFA) of small low risk papillary thyroid cancer is a promising therapeutic modality for these patients that reduces the risks associated with surgery and the anxiety of taking a watchful approach. However, this technique has not been validated in the North American population.
The investigators aim to describe the investigators' initial experience with RFA of low risk papillary thyroid microcarcinoma (PTMC) compared to active surveillance (AS) done by Head and Neck Endocrine surgeons at Johns Hopkins Medical Institute.
Primary objective:
Secondary objective:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency Ablation | Experimental | Patients will receive RFA as a one-time intervention, with a possible second treatment after 6 months if adequate resolution is not noted on ultrasound. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency Ablation | Procedure | Radiofrequency Ablation using RFMedical device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in nodule volume | This will assess the percentage change in nodule volume (cubic millimeters). | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in nodule volume | This will assess the percentage change in nodule volume (cubic millimeters). | Baseline and 6 months |
| Percentage change in nodule volume | This will assess the percentage change in nodule volume (cubic millimeters). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathon Russell, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21278 | United States |
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| ID | Term |
|---|---|
| D000077273 | Thyroid Cancer, Papillary |
| ID | Term |
|---|---|
| D000231 | Adenocarcinoma, Papillary |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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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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| Baseline and 24 months |
| Change in voice related quality of life as assessed by the VHI-10 | Change from baseline in Voice Handicap index (VHI-10) score. Score ranges from 0-40. Higher score indicates worse symptoms. | Baseline and 6 months |
| Change in voice related quality of life as assessed by the VHI-10 | Change from baseline in the VHI-10 score. Score ranges from 0-40. Higher score indicates worse symptoms. | Baseline and 12 months |
| Change in voice related quality of life as assessed by the VHI-10 | Change from baseline in the VHI-10 score. Score ranges from 0-40. Higher score indicates worse symptoms. | Baseline and 24 months |
| Scar cosmesis score | Average score on Scar cosmesis assessment and rating (SCAR) scale. Score ranges from 0-15. Higher score indicates worse scar. | 6 months |
| Scar cosmesis score | Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar. | 12 months |
| Scar cosmesis score | Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar. | 24 months |
| Change in eating assessment score as assessed by the EAT-10 | Change from baseline on Eating assessment tool (EAT-10) score. Score ranges from 0-40. Higher score indicates worse symptoms. | Baseline and 6 months |
| Change in eating assessment score as assessed by the EAT-10 | Change from baseline on EAT-10 score. Score ranges from 0-40. Higher score indicates worse symptoms. | Baseline and 12 months |
| Change in eating assessment score as assessed by the EAT-10 | Change from baseline on EAT-10 score. Score ranges from 0-40. Higher score indicates worse symptoms. | Baseline and 24 months |
| Change in overall quality of life assessed by the PROMIS score | Change from baseline on Patient-Reported Outcomes Measurement Information System (PROMIS)-29 score. Score ranges from 0-100. Higher score indicates worse symptoms. | Baseline and 6 months |
| Change in overall quality of life assessed by the PROMIS score | Change from baseline on PROMIS-29 score. Score ranges from 0-100. Higher score indicates worse symptoms. | Baseline and 12 months |
| Change in overall quality of life assessed by the PROMIS score | Change from baseline on PROMIS-29 score. Score ranges from 0-100. Higher score indicates worse symptoms. | Baseline and 24 months |
| Number of complications | Counts of skin burn, hematoma and vocal cord palsy. | 12 months |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |