Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-30 @ 10:42 PM
Study NCT ID:
NCT05003856
Status:
TERMINATED
Last Update Posted:
2025-04-02
First Post:
2021-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiofrequency Ablation for the Treatment of Benign or Low Risk Thyroid Nodule
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Radiofrequency Ablation Use in Thyroid Nodule
Status:
TERMINATED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administrativley Complete, 75%\<Participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase IV trial studies the effect of radiofrequency ablation in treating patients with benign or low risk thyroid nodule. Radiofrequency ablation uses a needle to deliver a high-frequency electric current to kill tumor cells by heating them. The goal of this research study is to learn if ultrasound guided radiofrequency ablation can provide the same treatment result as standard surgical removal of the thyroid nodule, small primary thyroid, or thyroid cancers that have come back. Researchers also want to learn if the procedure can be less invasive and perhaps provide a better recovery response than surgery.
Detailed Description:
PRIMARY OBJECTIVE:
I. Evaluate the longitudinal thyroid nodule volume changes induced by radiofrequency ablation (RFA) during post procedure follow-up.
SECONDARY OBJECTIVES:
I. Evaluate treatment response to compressive and/or cosmetic symptoms that affect patient's quality of life.
II. Evaluate the sonographic features of the nodule induced by RFA.
III. Compare cost of ultrasound guided RFA to gold standard surgical thyroidectomy.
OUTLINE:
Patients undergo ultrasound guided RFA over 1-2 hours.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months.
I. Evaluate the longitudinal thyroid nodule volume changes induced by radiofrequency ablation (RFA) during post procedure follow-up.
SECONDARY OBJECTIVES:
I. Evaluate treatment response to compressive and/or cosmetic symptoms that affect patient's quality of life.
II. Evaluate the sonographic features of the nodule induced by RFA.
III. Compare cost of ultrasound guided RFA to gold standard surgical thyroidectomy.
OUTLINE:
Patients undergo ultrasound guided RFA over 1-2 hours.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months.
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?: