Radiofrequency Ablation of Papillary Thyroid Microcarcinoma

NCT05132205 | Completed

• 1 other identifier: IRB00236242
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage change in nodule volume

  This will assess the percentage change in nodule volume (cubic millimeters).

  Baseline and 12 months

Secondary Outcomes (15)

• Percentage change in nodule volume

  Baseline and 6 months

• Percentage change in nodule volume

  Baseline and 24 months

• Change in voice related quality of life as assessed by the VHI-10

  Baseline and 6 months

• Change in voice related quality of life as assessed by the VHI-10

  Baseline and 12 months

• Change in voice related quality of life as assessed by the VHI-10

  Baseline and 24 months

Study Arms (1)

Radiofrequency Ablation

EXPERIMENTAL

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

Interventions

Radiofrequency Ablation PROCEDURE

Radiofrequency Ablation using RFMedical device.

Radiofrequency Ablation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• RF Medical Co., Ltd: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21278, United States

Location

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Jonathon Russell, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 24, 2021
• Study Start: December 17, 2021
• Primary Completion: November 19, 2024
• Study Completion: November 19, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)