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Completed

NCT Number: NCT05132205

Radiofrequency Ablation of Papillary Thyroid Microcarcinoma

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21278, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiofrequency ablation

Procedure

Radiofrequency Ablation using RFMedical device.

Primary outcomes

  1. Percentage change in nodule volume

    Time frame: Baseline and 12 months

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

Secondary outcomes

  1. Percentage change in nodule volume

    Time frame: Baseline and 6 months

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

  2. Percentage change in nodule volume

    Time frame: Baseline and 24 months

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

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

    Time frame: Baseline and 6 months

    Change from baseline in Voice Handicap index (VHI-10) score. Score ranges from 0-40. Higher score indicates worse symptoms.

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

    Time frame: Baseline and 12 months

    Change from baseline in the VHI-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.

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

    Time frame: Baseline and 24 months

    Change from baseline in the VHI-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.

  6. Scar cosmesis score

    Time frame: 6 months

    Average score on Scar cosmesis assessment and rating (SCAR) scale. Score ranges from 0-15. Higher score indicates worse scar.

  7. Scar cosmesis score

    Time frame: 12 months

    Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar.

  8. Scar cosmesis score

    Time frame: 24 months

    Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar.

  9. Change in eating assessment score as assessed by the EAT-10

    Time frame: Baseline and 6 months

    Change from baseline on Eating assessment tool (EAT-10) score. Score ranges from 0-40. Higher score indicates worse symptoms.

  10. Change in eating assessment score as assessed by the EAT-10

    Time frame: Baseline and 12 months

    Change from baseline on EAT-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.

  11. Change in eating assessment score as assessed by the EAT-10

    Time frame: Baseline and 24 months

    Change from baseline on EAT-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.

  12. Change in overall quality of life assessed by the PROMIS score

    Time frame: Baseline and 6 months

    Change from baseline on Patient-Reported Outcomes Measurement Information System (PROMIS)-29 score. Score ranges from 0-100. Higher score indicates worse symptoms.

  13. Change in overall quality of life assessed by the PROMIS score

    Time frame: Baseline and 12 months

    Change from baseline on PROMIS-29 score. Score ranges from 0-100. Higher score indicates worse symptoms.

  14. Change in overall quality of life assessed by the PROMIS score

    Time frame: Baseline and 24 months

    Change from baseline on PROMIS-29 score. Score ranges from 0-100. Higher score indicates worse symptoms.

  15. Number of complications

    Time frame: 12 months

    Counts of skin burn, hematoma and vocal cord palsy.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • RF Medical Co., Ltd

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 24, 2021
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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