NCT05189808

Brief Summary

The purpose of this observational chart review study is to evaluate the efficacy and safety of Radiofrequency Ablation (RFA) for treatment of indeterminate thyroid nodules before and after RFA procedure. This is a data collection study in which the investigators ask patients to give access to information generated before and after RFA treatment of their condition. The RFA procedure uses image guidance to place an electrode through the skin into the target area. In RFA, high-frequency electrical currents are passed through an electrode, creating a small region of heat to treat the lesion.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
15mo left

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Aug 2020Aug 2027

Study Start

First participant enrolled

August 1, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

6 years

First QC Date

December 28, 2021

Last Update Submit

May 27, 2025

Conditions

Indeterminate Bethesda III Thyroid Nodules

Keywords

Radiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

  • Change in Nodule Volume

    ((Volume (baseline) - Volume (12m))/Volume(baseline))\*100

    12 months

Secondary Outcomes (1)

  • Complications

    12 months

Study Arms (1)

Group

Procedure: Radiofrequency Ablation

Interventions

Radiofrequency AblationPROCEDURE

Ultrasound guided radiofrequency ablation (non-experimental)

Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (\>/= 18 years) who have biopsy proven indeterminate thyroid nodules (Bethesda III only) that have been molecular profiled benign, who refuse to undergo or are not good candidates for surgical resection

You may qualify if:

  • Indeterminate Bethesda III nodules that have been molecularly profiled benign with either Afirma Genomic Sequencing Classifier (GSC) or ThyroSeq v3 tests

You may not qualify if:

  • cardiac arrthymias
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10032, United States

RECRUITING

Related Publications (10)

  • Durante C, Costante G, Lucisano G, Bruno R, Meringolo D, Paciaroni A, Puxeddu E, Torlontano M, Tumino S, Attard M, Lamartina L, Nicolucci A, Filetti S. The natural history of benign thyroid nodules. JAMA. 2015 Mar 3;313(9):926-35. doi: 10.1001/jama.2015.0956.

    PMID: 25734734BACKGROUND

  • de Rienzo-Madero B, Sabra JP, Gand E, Donatini G, Kraimps JL. Unilateral benign multinodular versus solitary goiter: Long-term contralateral reoperation rates after lobectomy. Surgery. 2019 Jan;165(1):75-79. doi: 10.1016/j.surg.2018.04.074. Epub 2018 Nov 8.

    PMID: 30415868BACKGROUND

  • Kim YS, Rhim H, Tae K, Park DW, Kim ST. Radiofrequency ablation of benign cold thyroid nodules: initial clinical experience. Thyroid. 2006 Apr;16(4):361-7. doi: 10.1089/thy.2006.16.361.

    PMID: 16646682BACKGROUND

  • Na DG, Lee JH, Jung SL, Kim JH, Sung JY, Shin JH, Kim EK, Lee JH, Kim DW, Park JS, Kim KS, Baek SM, Lee Y, Chong S, Sim JS, Huh JY, Bae JI, Kim KT, Han SY, Bae MY, Kim YS, Baek JH; Korean Society of Thyroid Radiology (KSThR); Korean Society of Radiology. Radiofrequency ablation of benign thyroid nodules and recurrent thyroid cancers: consensus statement and recommendations. Korean J Radiol. 2012 Mar-Apr;13(2):117-25. doi: 10.3348/kjr.2012.13.2.117. Epub 2012 Mar 7.

    PMID: 22438678BACKGROUND

  • Kim JH, Baek JH, Lim HK, Ahn HS, Baek SM, Choi YJ, Choi YJ, Chung SR, Ha EJ, Hahn SY, Jung SL, Kim DS, Kim SJ, Kim YK, Lee CY, Lee JH, Lee KH, Lee YH, Park JS, Park H, Shin JH, Suh CH, Sung JY, Sim JS, Youn I, Choi M, Na DG; Guideline Committee for the Korean Society of Thyroid Radiology (KSThR) and Korean Society of Radiology. 2017 Thyroid Radiofrequency Ablation Guideline: Korean Society of Thyroid Radiology. Korean J Radiol. 2018 Jul-Aug;19(4):632-655. doi: 10.3348/kjr.2018.19.4.632. Epub 2018 Jun 14.

    PMID: 29962870BACKGROUND

  • Gharib H, Papini E, Garber JR, Duick DS, Harrell RM, Hegedus L, Paschke R, Valcavi R, Vitti P; AACE/ACE/AME Task Force on Thyroid Nodules. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS, AMERICAN COLLEGE OF ENDOCRINOLOGY, AND ASSOCIAZIONE MEDICI ENDOCRINOLOGI MEDICAL GUIDELINES FOR CLINICAL PRACTICE FOR THE DIAGNOSIS AND MANAGEMENT OF THYROID NODULES--2016 UPDATE. Endocr Pract. 2016 May;22(5):622-39. doi: 10.4158/EP161208.GL.

    PMID: 27167915BACKGROUND

  • Jeong WK, Baek JH, Rhim H, Kim YS, Kwak MS, Jeong HJ, Lee D. Radiofrequency ablation of benign thyroid nodules: safety and imaging follow-up in 236 patients. Eur Radiol. 2008 Jun;18(6):1244-50. doi: 10.1007/s00330-008-0880-6. Epub 2008 Feb 20.

    PMID: 18286289BACKGROUND

  • Baek JH, Kim YS, Lee D, Huh JY, Lee JH. Benign predominantly solid thyroid nodules: prospective study of efficacy of sonographically guided radiofrequency ablation versus control condition. AJR Am J Roentgenol. 2010 Apr;194(4):1137-42. doi: 10.2214/AJR.09.3372.

    PMID: 20308523BACKGROUND

  • Watt T, Barbesino G, Bjorner JB, Bonnema SJ, Bukvic B, Drummond R, Groenvold M, Hegedus L, Kantzer V, Lasch KE, Marcocci C, Mishra A, Netea-Maier R, Ekker M, Paunovic I, Quinn TJ, Rasmussen AK, Russell A, Sabaretnam M, Smit J, Torring O, Zivaljevic V, Feldt-Rasmussen U. Cross-cultural validity of the thyroid-specific quality-of-life patient-reported outcome measure, ThyPRO. Qual Life Res. 2015 Mar;24(3):769-80. doi: 10.1007/s11136-014-0798-1. Epub 2014 Sep 7.

    PMID: 25194574BACKGROUND

  • Dobnig H, Amrein K. Monopolar Radiofrequency Ablation of Thyroid Nodules: A Prospective Austrian Single-Center Study. Thyroid. 2018 Apr;28(4):472-480. doi: 10.1089/thy.2017.0547. Epub 2018 Mar 20.

    PMID: 29490593BACKGROUND

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Jennifer H Kuo, MD MS

    Columbia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer H Kuo, MD MS

CONTACT

212-305-6969jhk2029@cumc.columbia.edu

Catherine McManus, MD MS

CONTACT

212-305-6969cm3304@cumc.columbia.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 28, 2021

First Posted

January 13, 2022

Study Start

August 1, 2020

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)