Ultrasound-Guided Microwave Ablation Vs. Surgery for Low-Risk PapilaryThyroid Carcinoma
NCT ID: NCT06725576
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
201 participants
OBSERVATIONAL
2022-01-01
2025-03-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ablation Group
Patients in this group received ablation therapy for low-risk papillary thyroid carcinoma. The ablation method used was microwave ablation (MWA), with ablation performed under ultrasound guidance. Patients were informed of the potential risks and benefits of ablation, and follow-ups were conducted at regular intervals using thyroid ultrasound and contrast-enhanced ultrasound to evaluate treatment efficacy and disease progression.
Ablation
Thyroid ablation performed under ultrasound guidance to treat low-risk papillary thyroid carcinoma.
Surgery Group
Patients in this group underwent surgical treatment for low-risk papillary thyroid carcinoma. The surgery performed was partial or total thyroidectomy, based on the patient's condition and preferences. Patients were informed of the risks, including potential complications such as hypothyroidism, recurrent laryngeal nerve injury, and hypoparathyroidism. Follow-ups were conducted using thyroid ultrasound and clinical assessments to monitor for recurrence and evaluate postoperative recovery.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ablation
Thyroid ablation performed under ultrasound guidance to treat low-risk papillary thyroid carcinoma.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Confirmed low-risk mutation types by next-generation sequencing (NGS) before surgery;
3. No severe functional diseases, such as heart failure, severe respiratory diseases, or renal failure;
4. Availability of complete follow-up data.
Exclusion Criteria
2. Lacking of preoperative genetic testing or inability to assess genetic test results;
3. Inability to complete follow-up or lost to follow-up during the study.
Low-risk PTC is defined as:
1. Maximum tumor diameter ≤1 cm;
2. Solitary lesion;
3. No local or distant metastasis;
4. No tumor invasion into extrathyroidal tissues;
5. No vascular invasion;
6. Non-invasive pathological subtype for the primary lesion (invasive subtypes include tall cell, columnar cell, diffuse sclerosing, solid/trabecular, and oncocytic vari ants);
7. No history of head and neck radiotherapy during adolescence;
8. No family history of thyroid cancer;
9. 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:
1. Maximum tumor diameter \>1 cm;
2. Multifocal thyroid cancer;
3. Local or distant metastasis;
4. Primary lesion with extrathyroidal extension;
5. Vascular invasion;
6. Primary lesion with an invasive pathological subtype;
7. History of head and neck radiotherapy during adolescence;
8. Family history of thyroid cancer;
9. 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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Natural Science Foundation of China
OTHER_GOV
Guangzhou Science and Technology Innovation Commission,China
UNKNOWN
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Longmiaoyun
Chief Physician
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Miaoyun Long, MD
Role: STUDY_DIRECTOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Miaoyun Long, MD
Role: primary
Yuxin Shen, MBBS
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
No. 82404087
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
No.2023A1515011214
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
No. 2023A03J0722
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
No. 2024A03J1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SYSKY-2024-169-01
Identifier Type: -
Identifier Source: org_study_id