NCT05132205Completed
Radiofrequency Ablation of Papillary Thyroid Microcarcinoma
Source: ClinicalTrials.gov · Last updated 30 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 10 Nov 2021
- Start date
- 17 Dec 2021
- Primary completion date
- 19 Nov 2024
- Lead sponsor
- Johns Hopkins University
- Diseases
- Thyroid cancer
- NCT number
- NCT05132205
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 17 Dec 2021 to the primary completion date, 19 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous RFA.
Other illness
- 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
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.