Radiofrequency Ablation of Papillary Thyroid Microcarcinoma

Not Applicable

Active, not recruiting

• Conditions: Papillary Thyroid Cancer
• Interventions: Procedure: Radiofrequency Ablation

• Registration Number: NCT05132205
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-24
• Study Start: 2021-12-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-08
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiofrequency Ablation	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.

Primary Outcome Measures

Name	Time	Method
Percentage change in nodule volume	Baseline and 12 months	This will assess the percentage change in nodule volume (cubic millimeters).

Secondary Outcome Measures

Name	Time	Method
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 24 months	Change from baseline in the VHI-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.
Number of complications	12 months	Counts of skin burn, hematoma and vocal cord palsy.
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 24 months	Change from baseline on PROMIS-29 score. Score ranges from 0-100. Higher score indicates worse symptoms.
Scar cosmesis score	24 months	Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States