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NCT Number: NCT06725576

Ultrasound-Guided Microwave Ablation Vs. Surgery for Low-Risk PapilaryThyroid Carcinoma

This study aims to investigate the efficacy and prognosis of ultrasound-guided and gene-based microwave ablation (MWA) versus surgical treatment in patients with low-risk papillary thyroid carcinoma (PTC). By analyzing genetic testing results, the study explores the impact of genetic mutations on treatment selection for low-risk patients, providing more precise molecular biological evidence for treatment choices and prognosis evaluation of thyroid cancer. This prospective study collects clinical data from patients diagnosed with PTC at Sun Yat-sen Memorial Hospital of Sun Yat-sen University between January 2022 and November 2024, who underwent genetic testing prior to treatment, and assesses efficacy and complications through long-term follow-up.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Objective: This study evaluates and compares the efficacy and prognosis of ultrasound and gene-based microwave ablation (MWA) and surgical treatment in patients with low-risk papillary thyroid carcinoma (PTC), emphasizing the influence of genetic mutations on low-risk patients' selection.

Background: MWA, a minimally invasive technique, is increasingly recognized in the management of PTC. While traditional criteria for ablation focus on tumor size, number, and location, the impact of genetic mutations on treatment efficacy remains underexplored.

Methods: A total of 201 patients with low-risk PTC without metastasis were prospectively enrolled. All patients underwent ultrasound and next-generation sequencing to confirm low-risk status. Patients chose either ablation or surgery and were monitored until November 2024. Efficacy and complications were assessed using thyroid ultrasound and contrast-enhanced ultrasound.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria of this study were as followed:

  • PTC confirmed by fine-needle aspiration (FNA);
  • Confirmed low-risk mutation types by next-generation sequencing (NGS) before surgery;
  • No severe functional diseases, such as heart failure, severe respiratory diseases, or renal failure;
  • Availability of complete follow-up data.

The exclusion criteria were as followed:

  • No local or distant metastasis assessed by imaging evaluations, including ultrasound or computed tomography (CT);
  • Lacking of preoperative genetic testing or inability to assess genetic test results;
  • Inability to complete follow-up or lost to follow-up during the study.

Low-risk PTC is defined as:

  • Maximum tumor diameter ≤1 cm;
  • Solitary lesion;
  • No local or distant metastasis;
  • No tumor invasion into extrathyroidal tissues;
  • No vascular invasion;
  • Non-invasive pathological subtype for the primary lesion (invasive subtypes include tall cell, columnar cell, diffuse sclerosing, solid/trabecular, and oncocytic vari ants);
  • No history of head and neck radiotherapy during adolescence;
  • No family history of thyroid cancer;
  • Genetic testing showing BRAF V600E mutation (without concurrent TERT mutation), RAS family gene mutations, (HRAS, NRAS, KRAS), or other low-risk mutations, such as isolated RET/PTC) rearrangements.

Intermediate-high risk PTC is defined as:

  • Maximum tumor diameter >1 cm;
  • Multifocal thyroid cancer;
  • Local or distant metastasis;
  • Primary lesion with extrathyroidal extension;
  • Vascular invasion;
  • Primary lesion with an invasive pathological subtype;
  • History of head and neck radiotherapy during adolescence;
  • Family history of thyroid cancer;
  • Genetic testing revealing high-risk mutation combinations, such as BRAF V600E or RAS mutations with concurrent TERT or TP53 mutations, or RAS mutations combined with EIF1AX mutations.

Treatment and study plan

Ablation

Procedure

Thyroid ablation performed under ultrasound guidance to treat low-risk papillary thyroid carcinoma.

Primary outcomes

  1. Disease progression

    Time frame: through study completion, an average of 1 year

    The primary endpoint was disease progression, defined as: (1) local recurrence or cervical lymph node metastasis confirmed by FNA; (2) Distant organ metastasis; (3) Death due to tumor progression.

Secondary outcomes

  1. Complications

    Time frame: through study completion, an average of 1 year

    Such as permanent or transient hypoparathyroidism, recurrent laryngeal nerve injury, postoperative hypertension, infection, fever, pain, and nausea or vomiting. Permanent hypoparathyroidism was defined as the need for calcium or vitamin D supplementation beyond six months, while transient hypoparathyroidism indicated recovery within six months. Permanent recurrent laryngeal nerve injury was defined as persistent voice changes beyond six months, while transient injury indicated recovery within six months.

  2. Treatment costs

    Time frame: through study completion, an average of 1 year

    Including preoperative tests and treatment costs

  3. Time of hospital stay

    Time frame: from admission to discharge, up to 1 week.

    The total duration of hospital stay from admission to discharge.

  4. Operative time

    Time frame: immediately after the intervention

    Time from the start of surgery to the completion of surgery.

  5. Ablation efficacy

    Time frame: Follow-up examination one month after treatment.

    Defined as complete or incomplete ablation based on Contrast-enhanced ultrasound (CEUS).

  6. Changes in ablation zone volume

    Time frame: through study completion, an average of 1 year

    Measured before and after treatment

  7. Thyroid function

    Time frame: through study completion, an average of 1 year

    The proportion of patients with thyroid dysfunction after treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Miaoyun Long, MD

CONTACT

[email protected]

86-34070602

Yuxin Shen, MBBS

CONTACT

[email protected]

86-15083138712

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Collaborators

  • Guangzhou Science and Technology Innovation Commission,China
  • National Natural Science Foundation of China

Registry information

Official study title

Ultrasound and Gene-Guided Microwave Ablation Versus Surgery for Low-Risk Papillary Thyroid Carcinoma: a Prospective Observational Cohort Study.

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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