Clinical trial NCT05132205: Radiofrequency Ablation of Papillary Thyroid Microcarcinoma
Official title: Radiofrequency Ablation of Papillary Thyroid Microcarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Papillary Thyroid Cancer
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: RF Medical Co., Ltd
First posted: 2021-11-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage change in nodule volume
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Percentage change in nodule volume
timeFrame: Baseline and 6 months
measure: Percentage change in nodule volume
timeFrame: Baseline and 24 months
measure: Change in voice related quality of life as assessed by the VHI-10
timeFrame: Baseline and 6 months
measure: Change in voice related quality of life as assessed by the VHI-10
timeFrame: Baseline and 12 months
measure: Change in voice related quality of life as assessed by the VHI-10
timeFrame: Baseline and 24 months
measure: Scar cosmesis score
timeFrame: 6 months
measure: Scar cosmesis score
timeFrame: 12 months
measure: Scar cosmesis score
timeFrame: 24 months
measure: Change in eating assessment score as assessed by the EAT-10
timeFrame: Baseline and 6 months
measure: Change in eating assessment score as assessed by the EAT-10
timeFrame: Baseline and 12 months
measure: Change in eating assessment score as assessed by the EAT-10
timeFrame: Baseline and 24 months
measure: Change in overall quality of life assessed by the PROMIS score
timeFrame: Baseline and 6 months
measure: Change in overall quality of life assessed by the PROMIS score
timeFrame: Baseline and 12 months
measure: Change in overall quality of life assessed by the PROMIS score
timeFrame: Baseline and 24 months
measure: Number of complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jonathon Russell, MD
role: PRINCIPAL_INVESTIGATOR
References: