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

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Brief Title

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

Official Title

Radiofrequency Ablation Use in Thyroid Nodule

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Changes in thyroid nodule size

Secondary Outcome

 Treatment response that affect quality of life

Condition

Benign Thyroid Gland Neoplasm

Intervention

Quality-of-Life Assessment

Study Arms / Comparison Groups

 Treatment (RFA)
Description:  Patients undergo ultrasound guided RFA over 1-2 hours.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

100

Start Date

September 30, 2021

Completion Date

June 30, 2025

Primary Completion Date

June 30, 2025

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kim O Learned, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05003856

Organization ID

2021-0542

Secondary IDs

NCI-2021-08354

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center


Study Sponsor

Kim O Learned, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

August 2021