Radiofrequency Ablation for Management of Benign/Indeterm... | NCT07140757

Studies
Radiofrequency Ablation for Management of Benign/Indeterminate Thyroid Nodules and Low Risk Papillary Thyroid Cancers

NCT07140757

Sponsor

M.D. Anderson Cancer Center

Status

Recruiting

Last Update Posted

Mar 11, 2026Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Low Risk
Papillary Thyroid Cancer
Radiofrequency Ablation

Interventions

Questionnaire

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2025-06179	Other Identifier	NCI-CTRP Clinical Registry

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 18, 2025Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2030Estimated

First Submitted Date

Aug 22, 2025

First Submission Date that Met QC Criteria

Aug 22, 2025

First Posted Date

Aug 26, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2026

Last Update Posted Date

Mar 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To track the outcomes of patients who have been treated with RFA and its long-term effectiveness, and to learn more about the quality of life of patients who have received RFA in this study.

Detailed Description

Primary Objectives

• To evaluate thyroid nodule volume changes over time in participants undergoing RFA as part of clinical care

Secondary Objectives

To establish the health-related quality of life among participants undergoing with ultrasound guided RFA.
To evaluate the sonographic features of thyroid nodules over time following ultrasound guided RFA.
To assess adverse events rates following ultrasound guided RFA.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	This questionnaire includes twenty-four questions covering patients complaints ranging from 0 to 4. Patients will be asked about the presence and severity of each item currently on the medical appointment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Health- related Quality of Life Questionnaires	This questionnaire includes twenty-four questions covering patients complaints ranging from 0 to 4. Patients will be asked about the presence and severity of each item currently on the medical appointment.	Through study completion; an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Participants scheduled to undergo ultrasound-guided RFA for the following conditions: benign thyroid nodules, indeterminate thyroid nodules, low-risk DTC, and recurrent PTC
Participant is over 18 years and is either not a surgical candidate or has declined surgery.
Capable and willing to provide written informed consent
Participant has one of the following diagnoses:
- Biopsy-proven benign thyroid nodules causing compressive and/or cosmetic symptoms who are requesting treatment,
- Biopsy-proven indeterminate nodules (AUS or follicular neoplasm)
- Papillary thyroid carcinoma (PTC) without metastasis
- Locally recurrent thyroid cancer (< 2 cm).

Exclusion Criteria

Participants meeting any of the following criteria will be excluded:
Participants considered unsuitable for RFA by the treating physician

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

MD Anderson Cancer Center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Victoria E Banuchi, MD	Contact	346-217-8668		vebanuchi@mdanderson.org

Overall Officials

Name	Affiliation	Role
Victoria E Banuchi, MD	M.D. Anderson Cancer Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MD Anderson Cancer Center	Recruiting	Houston	Texas	77030	United States

Label	URL
MD Anderson Cancer Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D000077273	Thyroid Cancer, Papillary

Ancestor Terms

ID	Term
D000231	Adenocarcinoma, Papillary
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided