Radiofrequency Ablation of Papillary Thyroid Microcarcinoma

NCT ID: NCT05132205

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-17
• Study Completion Date: 2024-11-19

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.

Conditions

Papillary Thyroid Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Radiofrequency Ablation

Intervention Type: PROCEDURE

Radiofrequency Ablation using RFMedical device.

Interventions

Radiofrequency Ablation

Radiofrequency Ablation using RFMedical device.

Intervention Type: PROCEDURE

Eligibility 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).
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RF Medical Co., Ltd

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathon Russell, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00236242

Identifier Type: -

Identifier Source: org_study_id