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Radiofrequency Ablation for the Treatment of Benign or Low Risk Thyroid Nodule

Primary Purpose

Benign Thyroid Gland Neoplasm, Recurrent Thyroid Gland Carcinoma, Thyroid Gland Follicular Tumor of Uncertain Malignant Potential

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quality-of-Life Assessment
Radiofrequency Ablation
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Benign Thyroid Gland Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient is older than 18 years, is not a surgical candidate or refuses to have surgery
  • Patient is medically fit to undergo local anesthesia with or without conscious sedation
  • Patient is able to understand and give consent to participation in the study
  • Presence of compression symptoms or cosmetic concerns for which patient request treatment of the benign thyroid nodule
  • Solitary thyroid nodule or dominating nodule that is well-defined in multinodular goiter
  • Benign nodule is >= 2 cm in the largest dimension, and has either solid, or predominantly solid composition (>= 70% volume) without large calcification. Nodule is confirmed as benign (Bethesda II) on at least 2 ultrasound guided fine needle aspirations (FNA) or core needle biopsy (CNB) or a single benign diagnosis of FNA or CNB when the nodule has benign ultrasound features (American College of Radiology [ACR] Thyroid Imaging Reporting & Data System [TI-RAD] TR 1-3, American Thyroid Association [ATA] very low suspicion) within 6 months of planned RFA
  • Indeterminate thyroid nodule (atypical cells of undetermined significance [ACUS], follicular neoplasm), papillary thyroid carcinoma (PTC) without metastasis or locally recurrent thyroid cancer < 2 cm in the largest dimension. Nodule cytology is confirmed on a single FNA or CNB when the nodule has concordant ultrasound features (ACR TI-RAD TR 4-5, ATA intermediate-high suspicion) within 6 months of planned RFA
  • Entirety of the selected nodule is visible on ultrasound without significant extension posterior to trachea or mediastinal component
  • Selected nodule is amenable to trans-isthmus approach
  • Normal complete blood count, blood coagulation, serum levels of thyroid hormones, thyrotropin (TSH), calcitonin, and absence of anti-thyroglobulin antibodies (TgAb) and anti-thyroid peroxidase antibodies (TPOAb)
  • Patient agrees to participate in the clinical study and to complete all required visits and evaluations
  • Negative serum or urine pregnancy test for females of childbearing potential at base line pre-procedure evaluation

Exclusion Criteria:

  • Patients with cardiac arrhythmia and/or implanted cardiac device
  • Hyper-functioning nodules, evaluated by thyroid function test and/or 99mTc-pertechnetate scintigraphic findings
  • History of neck radiation therapy
  • Pregnancy
  • Allergies to medications for anesthesia
  • Primary thyroid PTC with aggressive histology (tall cell, columnar cell, insular, e.g.) in consultation with cytology, endocrine and surgery team
  • Extra-thyroidal invasion of PTC OR local nodal/distant systemic metastatic disease
  • Cystic nodules (< 70% solid components)
  • Calcified nodules
  • Targeted nodule within 0.5 cm from the major vessels, vagus nerve, brachial plexus, and recurrent laryngeal nerve
  • Patients with contralateral vocal cord paralysis
  • Uncorrectable coagulopathy with partial thromboplastin time (PTT) > 1.5 x upper limit of normal (ULN) or international normalized ratio (INR) > 1.5 or platelet count <100,000 per mm^3

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (RFA)

Arm Description

Patients undergo ultrasound guided RFA over 1-2 hours.

Outcomes

Primary Outcome Measures

Changes in thyroid nodule size
The change from baseline to follow-up will be evaluated using Wilcoxon signed-rank tests. Additionally, will assess the association between changes in the nodule volume and covariates of interest, including but not excluded to the percentage of volume ablated, the nodule composition at treatment and follow-up, and the amount of energy delivered in Joules.

Secondary Outcome Measures

Treatment response that affect quality of life
Will compare symptom scores and cosmetic grades to baseline using Wilcoxon signed-rank tests at both 6 months and at 12 months of follow-up.
Sonographic features of nodules
Sonographic features will be summarized descriptively.
Cost of ultrasound-guided radiofrequency ablation (RFA)
The cost of ultrasound-guided RFA will be summarized. Comparisons may be made with historical data on the costs associated with surgical thyroidectomy.

Full Information

First Posted
August 5, 2021
Last Updated
September 20, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05003856
Brief Title
Radiofrequency Ablation for the Treatment of Benign or Low Risk Thyroid Nodule
Official Title
Radiofrequency Ablation Use in Thyroid Nodule
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Thyroid Gland Neoplasm, Recurrent Thyroid Gland Carcinoma, Thyroid Gland Follicular Tumor of Uncertain Malignant Potential, Thyroid Gland Nodule, Thyroid Gland Papillary Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (RFA)
Arm Type
Experimental
Arm Description
Patients undergo ultrasound guided RFA over 1-2 hours.
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency Ablation
Other Intervention Name(s)
Ablation, Radiofrequency, Radiofrequency Interstitial Ablation, RFA
Intervention Description
Undergo RFA
Primary Outcome Measure Information:
Title
Changes in thyroid nodule size
Description
The change from baseline to follow-up will be evaluated using Wilcoxon signed-rank tests. Additionally, will assess the association between changes in the nodule volume and covariates of interest, including but not excluded to the percentage of volume ablated, the nodule composition at treatment and follow-up, and the amount of energy delivered in Joules.
Time Frame
Baseline up to 12 months
Secondary Outcome Measure Information:
Title
Treatment response that affect quality of life
Description
Will compare symptom scores and cosmetic grades to baseline using Wilcoxon signed-rank tests at both 6 months and at 12 months of follow-up.
Time Frame
Up to 12 months post-treatment
Title
Sonographic features of nodules
Description
Sonographic features will be summarized descriptively.
Time Frame
Up to 12 months post-treatment
Title
Cost of ultrasound-guided radiofrequency ablation (RFA)
Description
The cost of ultrasound-guided RFA will be summarized. Comparisons may be made with historical data on the costs associated with surgical thyroidectomy.
Time Frame
Up to 12 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is older than 18 years, is not a surgical candidate or refuses to have surgery Patient is medically fit to undergo local anesthesia with or without conscious sedation Patient is able to understand and give consent to participation in the study Presence of compression symptoms or cosmetic concerns for which patient request treatment of the benign thyroid nodule Solitary thyroid nodule or dominating nodule that is well-defined in multinodular goiter Benign nodule is >= 2 cm in the largest dimension, and has either solid, or predominantly solid composition (>= 70% volume) without large calcification. Nodule is confirmed as benign (Bethesda II) on at least 2 ultrasound guided fine needle aspirations (FNA) or core needle biopsy (CNB) or a single benign diagnosis of FNA or CNB when the nodule has benign ultrasound features (American College of Radiology [ACR] Thyroid Imaging Reporting & Data System [TI-RAD] TR 1-3, American Thyroid Association [ATA] very low suspicion) within 6 months of planned RFA Indeterminate thyroid nodule (atypical cells of undetermined significance [ACUS], follicular neoplasm), papillary thyroid carcinoma (PTC) without metastasis or locally recurrent thyroid cancer < 2 cm in the largest dimension. Nodule cytology is confirmed on a single FNA or CNB when the nodule has concordant ultrasound features (ACR TI-RAD TR 4-5, ATA intermediate-high suspicion) within 6 months of planned RFA Entirety of the selected nodule is visible on ultrasound without significant extension posterior to trachea or mediastinal component Selected nodule is amenable to trans-isthmus approach Normal complete blood count, blood coagulation, serum levels of thyroid hormones, thyrotropin (TSH), calcitonin, and absence of anti-thyroglobulin antibodies (TgAb) and anti-thyroid peroxidase antibodies (TPOAb) Patient agrees to participate in the clinical study and to complete all required visits and evaluations Negative serum or urine pregnancy test for females of childbearing potential at base line pre-procedure evaluation Exclusion Criteria: Patients with cardiac arrhythmia and/or implanted cardiac device Hyper-functioning nodules, evaluated by thyroid function test and/or 99mTc-pertechnetate scintigraphic findings History of neck radiation therapy Pregnancy Allergies to medications for anesthesia Primary thyroid PTC with aggressive histology (tall cell, columnar cell, insular, e.g.) in consultation with cytology, endocrine and surgery team Extra-thyroidal invasion of PTC OR local nodal/distant systemic metastatic disease Cystic nodules (< 70% solid components) Calcified nodules Targeted nodule within 0.5 cm from the major vessels, vagus nerve, brachial plexus, and recurrent laryngeal nerve Patients with contralateral vocal cord paralysis Uncorrectable coagulopathy with partial thromboplastin time (PTT) > 1.5 x upper limit of normal (ULN) or international normalized ratio (INR) > 1.5 or platelet count <100,000 per mm^3
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kim Learned, MD
Phone
281-224-6455
Email
kolearned@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim O Learned
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim O. Learned, MD
Phone
281-224-6455
Email
kolearned@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Kim O. Learned, MD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

Radiofrequency Ablation for the Treatment of Benign or Low Risk Thyroid Nodule

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