Radiofrequency Ablation of Papillary Thyroid Microcarcinoma

Papillary Thyroid Cancer Clinical Trial

Official title:

Radiofrequency Ablation of Papillary Thyroid Microcarcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05132205
• Other study ID #: IRB00236242
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 17, 2021
• Est. completion date: September 28, 2024

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: September 28, 2024
• Est. primary completion date: September 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).
• Solitary thyroid nodule <20mm in maximal dimension.
• No sonographic evidence of extrathyroidal invasion, lymph node metastases, or distant metastases.
• There must be at least 1 mm of normal tissue as a margin, without sonographic evidence of contact with the capsule.

Exclusion Criteria:

• 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
• Clinically apparent multicentricity
• Lesions larger than 20 mm in maximum diameter.
• Recurrent laryngeal nerve palsy.
• Extension of nodule to posterior thyroid capsule.
• Ultrasound or other imaging studies revealing cervical lymph node involvement or distant metastases.
• Pregnancy.
• Pacemaker.
• Previous RFA.

Related Conditions & MeSH terms

• Papillary Thyroid Cancer
• Thyroid Cancer, Papillary
• Thyroid Diseases

Intervention

Procedure:
• Radiofrequency Ablation
Radiofrequency Ablation using RFMedical device.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in nodule volume	This will assess the percentage change in nodule volume (cubic millimeters).	Baseline and 12 months
Secondary	Percentage change in nodule volume	This will assess the percentage change in nodule volume (cubic millimeters).	Baseline and 6 months
Secondary	Percentage change in nodule volume	This will assess the percentage change in nodule volume (cubic millimeters).	Baseline and 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Scar cosmesis score	Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar.	12 months
Secondary	Scar cosmesis score	Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar.	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of complications	Counts of skin burn, hematoma and vocal cord palsy.	12 months