An interventional study of Radiofrequency Ablation in Papillary Thyroid Cancer, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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:
175 studies on the registry are indexed under Thyroid Cancer, Papillary; 52 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 108 interventional studies indexed under Thyroid Cancer, Papillary.
Browse Thyroid Cancer, Papillary studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Percentage change in nodule volume
This will assess the percentage change in nodule volume (cubic millimeters).
Time frame: Baseline and 12 months
Percentage change in nodule volume
This will assess the percentage change in nodule volume (cubic millimeters).
Time frame: Baseline and 6 months
Percentage change in nodule volume
This will assess the percentage change in nodule volume (cubic millimeters).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Scar cosmesis score
Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar.
Time frame: 12 months
Scar cosmesis score
Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 24 months
Number of complications
Counts of skin burn, hematoma and vocal cord palsy.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Johns Hopkins University