Efficacy and Prognosis of Microwave Ablation Treatment for Papillary Thyroid Microcarcinoma Assessed by Contrast-Enhanced Ultrasound Combined With Genetic and Molecular Diagnostics: A Prospective Observational Study

NCT07054229 | Recruiting

• 1 other identifier: SYSKY-2024-512-01
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

In 2016, there were 203,000 new cases of thyroid cancer in China, ranking 7th among all malignant tumours and 4th among women, and showing a rapid growth trend. Papillary thyroid cancer (PTMC) with a diameter of ≤10 mm is the most common type of thyroid cancer, accounting for about 50% to 60% of the total number of cases. Low-risk PTMC is the most common type of thyroid cancer, with low invasiveness and good prognosis. Surgery is the treatment of choice for low-risk PTMC, but it significantly affects the quality of life of patients by affecting the function of the thyroid gland and requiring long-term medication after surgery, as well as having a high incidence of intra- and postoperative complications; there are certain impacts and limitations in the actual treatment. Microwave ablation (MWA) is a therapeutic modality emerging in recent years, which has the characteristics of easy operation, precise positioning, safety and effectiveness, small postoperative damage, fast recovery, fewer complications, and does not affect the aesthetics of the patient, which not only avoids surgical trauma and reduces the anxiety of the patient, but also better preserves the function of the thyroid gland, and its clinical application is becoming more and more widespread. In recent years, the application of microwave ablation in the treatment of PTMC has received more and more attention. Ultrasound, as a first-line examination tool, is accepted by the majority of patients because of its advantages of safety, speed, efficiency, low price and painlessness. Contrast-enhanced ultrasound (CEUS) is a new examination technique developed in recent years, which can provide richer and clearer diagnostic information than conventional ultrasound and colour Doppler ultrasound. Ultrasound contrast agents (e.g. Sonovue, Sonazoid), Sonovue with sulphur hexafluoride microbubbles as the main ingredient and Sonazoid with perfluorobutane microbubbles as the main ingredient, are non-toxic, non-radioactive, do not require allergy testing, and do not have the advantages of liver or kidney toxicity, etc., and are increasingly recognised by the public. Ultrasonography is now widely used in clinical practice as the primary modality for assessing efficacy after thyroid ablation therapy. Molecular diagnosis is one of the most important tools for preoperative diagnosis and invasiveness assessment of thyroid cancer. Common thyroid cancer gene variants include point mutations such as BRAF V600E, RAS, TP53, PIK3CA, and gene integration variants such as CCDC6-RET and ETV6-NTRK3. This project intends to assess the efficacy and prognosis of microwave ablation therapy for micropapillary thyroid cancer by ultrasonography combined with genetic molecular diagnosis, which in turn will assist in clinical treatment decisions.

Conditions

Microwave Ablation; Contrast-enhanced Ultrasound; Genetic and Molecular Diagnostics; Papillary Thyroid Microcarcinoma

Keywords

microwave ablation; Papillary Thyroid Microcarcinoma; contrast-enhanced ultrasound; Genetic and Molecular Diagnostics

Outcome Measures

Primary Outcomes (1)

• Efficacy and prognosis of microwave ablation therapy for papillary thyroid microcarcinoma

  Record the absorption status of the ablated lesion: volume observed by ultrasound imaging after ablation, and assess for the presence or absence of lymph node metastasis.Then, we will compile the postoperative follow-up ultrasound data-including volume measurements and lymph node metastasis status-into an Excel spreadsheet.

  1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months postoperatively

Study Arms (1)

The thyroid nodule was confirmed to be papillary thyroid microcarcinoma by fine-needle aspiration bi

1. Aged 18-70 years, gender not specified; 2. Patients with low-risk PTMC receiving initial treatment (meeting all the following criteria: single lesion with a maximum diameter ≤1cm; no cervical lymph node metastasis; no distant metastasis; no extrathyroidal extension; no family history of thyroid cancer; no history of head and neck radiation during childhood); 3. Patients who have undergone fine-needle aspiration cytology examination of thyroid nodules and 88-gene testing for thyroid cancer before surgery; 4. Patients voluntarily choose to undergo microwave ablation therapy or surgical resection.

Drug: Contrast enhanced Ultrasound; Genetic: 88-gene panel for thyroid cancer

Interventions

Contrast enhanced Ultrasound DRUG

Contrast Enhanced Ultrasound (CEUS) refers to the observation under ultrasound after the injection of ultrasound contrast agents, such as SonoVue or Lumason.

Also known as: CEUS

The thyroid nodule was confirmed to be papillary thyroid microcarcinoma by fine-needle aspiration bi

88-gene panel for thyroid cancer GENETIC

"88-gene panel" refers to a testing combination that includes 88 genes, which are typically associated with the onset, progression, and prognosis of thyroid cancer.

The thyroid nodule was confirmed to be papillary thyroid microcarcinoma by fine-needle aspiration bi

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

480 patients who were diagnosed with low-risk papillary thyroid microcarcinoma (PTMC) confirmed by fine-needle aspiration biopsy at Sun Yat-sen Memorial Hospital, Sun Yat-sen University will be included between January 2024 and December 2026.

You may qualify if:

• Aged 18-70 years, gender not specified;
• Patients with low-risk PTMC receiving initial treatment (meeting all the following conditions: single lesion with a maximum diameter ≤1cm; no cervical lymph node metastasis; no distant metastasis; no extrathyroidal extension; no family history of thyroid cancer; no history of head and neck radiation during childhood);
• Patients who have undergone fine-needle aspiration cytology examination of thyroid nodules and 88-gene panel testing for thyroid cancer before surgery;
• Patients voluntarily choose to undergo microwave ablation therapy or surgical resection.

You may not qualify if:

• Tumor located in the isthmus of the thyroid;
• Pathological high-risk subtypes (tall cell subtype, columnar cell subtype, diffuse sclerosing subtype, solid/insular subtype, oncocytic subtype);
• Progressive enlargement of the cancer lesion in the short term (increase of more than 3mm within 6 months);
• Pregnant women, lactating women;
• Patients with severe coagulation disorders;
• Patients with contralateral vocal cord dysfunction;
• Patients with contraindications to ultrasound contrast agents;
• Other conditions deemed ineligible for enrollment by the investigator.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Papillary Thyroid Microcarcinoma

Study Officials

• Luo, Prof.

  Department of Ultrasound in Medicine, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Ou, Dr.

CONTACT

020-34071020; ouqy5@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 8, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE

Locations

CN (1)