Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-01-06 @ 9:01 AM
Study NCT ID:
NCT05132205
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2021-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiofrequency Ablation of Papillary Thyroid Microcarcinoma
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Radiofrequency Ablation of Papillary Thyroid Microcarcinoma
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: