Radiofrequency Ablation of Papillary Thyroid Microcarcinoma
Study Details
Study Description
Brief Summary
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:
- To evaluate the safety, efficacy and oncological outcomes of the procedure.
Secondary objective:
- To determine the patient functional outcomes in comparison to the observational control.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Radiofrequency Ablation 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. |
Procedure: Radiofrequency Ablation
Radiofrequency Ablation using RFMedical device.
|
Outcome Measures
Primary Outcome Measures
- Percentage change in nodule volume [Baseline and 12 months]
This will assess the percentage change in nodule volume (cubic millimeters).
Secondary Outcome Measures
- Percentage change in nodule volume [Baseline and 6 months]
This will assess the percentage change in nodule volume (cubic millimeters).
- Percentage change in nodule volume [Baseline and 24 months]
This will assess the percentage change in nodule volume (cubic millimeters).
- Change in voice related quality of life as assessed by the VHI-10 [Baseline and 6 months]
Change from baseline in Voice Handicap index (VHI-10) score. Score ranges from 0-40. Higher score indicates worse symptoms.
- Change in voice related quality of life as assessed by the VHI-10 [Baseline and 12 months]
Change from baseline in the VHI-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.
- Change in voice related quality of life as assessed by the VHI-10 [Baseline and 24 months]
Change from baseline in the VHI-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.
- Scar cosmesis score [6 months]
Average score on Scar cosmesis assessment and rating (SCAR) scale. Score ranges from 0-15. Higher score indicates worse scar.
- Scar cosmesis score [12 months]
Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar.
- Scar cosmesis score [24 months]
Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar.
- Change in eating assessment score as assessed by the EAT-10 [Baseline and 6 months]
Change from baseline on Eating assessment tool (EAT-10) score. Score ranges from 0-40. Higher score indicates worse symptoms.
- Change in eating assessment score as assessed by the EAT-10 [Baseline and 12 months]
Change from baseline on EAT-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.
- Change in eating assessment score as assessed by the EAT-10 [Baseline and 24 months]
Change from baseline on EAT-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.
- Change in overall quality of life assessed by the PROMIS score [Baseline and 6 months]
Change from baseline on Patient-Reported Outcomes Measurement Information System (PROMIS)-29 score. Score ranges from 0-100. Higher score indicates worse symptoms.
- Change in overall quality of life assessed by the PROMIS score [Baseline and 12 months]
Change from baseline on PROMIS-29 score. Score ranges from 0-100. Higher score indicates worse symptoms.
- Change in overall quality of life assessed by the PROMIS score [Baseline and 24 months]
Change from baseline on PROMIS-29 score. Score ranges from 0-100. Higher score indicates worse symptoms.
- Number of complications [12 months]
Counts of skin burn, hematoma and vocal cord palsy.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
All patients regardless of sex or race between the ages 18-100 with biopsy proven PTMC with a Bethesda V or VI pathology or indeterminate cytology on fine-needle aspiration cytology (FNAC) who are recommended for treatment (Bethesda III/IV).
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Solitary thyroid nodule <20mm in maximal dimension.
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No sonographic evidence of extrathyroidal invasion, lymph node metastases, or distant metastases.
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There must be at least 1 mm of normal tissue as a margin, without sonographic evidence of contact with the capsule.
Exclusion Criteria:
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Patients with other histological types of thyroid malignancy other than papillary thyroid cancer such as medullary carcinoma, Proto-oncogene serine/threonine kinase (BRAF) or Telomerase reverse transcriptase (TERT) mutations
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Clinically apparent multicentricity
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Lesions larger than 20 mm in maximum diameter.
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Recurrent laryngeal nerve palsy.
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Extension of nodule to posterior thyroid capsule.
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Ultrasound or other imaging studies revealing cervical lymph node involvement or distant metastases.
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Pregnancy.
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Pacemaker.
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Previous RFA.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins Hospital | Baltimore | Maryland | United States | 21278 |
Sponsors and Collaborators
- Johns Hopkins University
Investigators
- Principal Investigator: Jonathon Russell, MD, Johns Hopkins University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00236242