Thyroid TumorNCT07776262
Safety and Efficacy of Cryoablation for Thyroid Tumors
A study testing Ultrasound-guided percutaneous cryoablation of thyroid neoplasm and Ultrasound-guided percutaneous microwave ablation of thyroid neoplasm in people with Thyroid Tumor and Thyroid Neoplasm, run by Yukun Luo at 1 site in China.
Trial summary
The goal of this clinical study is to learn if cryoablation works to treat thyroid tumors. It will also learn about the safety of cryoablation for thyroid tumors. The main questions it aims to answer are: Does cryoablation shrink thyroid tumors over time? What side effects or problems do participants have after… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Tumor, Thyroid Neoplasm
- What is being tested?
- Ultrasound-guided percutaneous cryoablation of thyroid neoplasm and Ultrasound-guided percutaneous microwave ablation of thyroid neoplasm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 9 Feb 2026to 10 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 【Group 1: Papillary Thyroid Carcinoma (PTC) patients】
- Pre-operative ultrasound evaluation shows the maximum tumor diameter <1 cm;
- Papillary thyroid carcinoma (PTC) confirmed by ultrasound-guided fine-needle aspiration (FNA) biopsy;
- Solitary PTC confirmed by pre-operative ultrasound;
- Imaging examinations demonstrate no extrathyroidal invasion, cervical lymph node metastasis or distant metastasis.
- 【Group 2: Benign thyroid nodule patients】
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- Benign nodule confirmed by puncture biopsy;
- Preoperative ultrasound confirms solid nodule with maximum diameter greater than 2 cm;
- Patients refuse surgical treatment or cannot tolerate surgery, voluntarily receive thyroid ablation therapy and sign the informed consent form.
Who cannot join
- 【Group 1: Papillary Thyroid Carcinoma (PTC) patients】
- (1) Biopsy confirms high-risk subtype papillary thyroid carcinoma; (2) History of thyroid surgery or radiotherapy; (3) Complicated with malignant tumors in other sites; (4) Severe coagulation dysfunction, or patients taking oral anticoagulants who have not reached the required drug-withdrawal period; (5) Incomplete follow-up data. 【Group 2: Benign thyroid nodule patients】
- Patients with uncorrected psychiatric disorders or consciousness disturbance who cannot cooperate with treatment;
- Patients with neck extension disorders of various causes who cannot cooperate with treatment;
- Severe coagulation dysfunction, or patients taking oral anticoagulants who have not completed the required drug withdrawal period;
- Severe cardiopulmonary insufficiency and inability to lie supine for the procedure;
- Unrecovered recurrent laryngeal nerve injury contralateral to the lesion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100853
Yukun Luo, MD, +86 010-6693 9533, lyk301@163.com
About this study
Official title: Study on the Safety and Efficacy of Cryoablation Therapy for Thyroid Tumors
The goal of this clinical study is to learn if cryoablation works to treat thyroid tumors. It will also learn about the safety of cryoablation for thyroid tumors. The main questions it aims to answer are:
- Does cryoablation shrink thyroid tumors over time?
- What side effects or problems do participants have after cryoablation?
Participants will receive cryoablation treatment guided by ultrasound. Researchers will track tumor size changes and check for any safety issues during follow-up visits.
- Conditions
- Thyroid Tumor, Thyroid Neoplasm
- Being tested
- Ultrasound-guided percutaneous cryoablation of thyroid neoplasm, Ultrasound-guided percutaneous microwave ablation of thyroid neoplasm
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided percutaneous cryoablation of thyroid neoplasmProcedure or surgery
Under local anesthesia, ultrasound-guided percutaneous cryoablation is applied to treat thyroid neoplasms. Targeted tumor tissue is destroyed by ultralow temperature from cryoprobes.
Ultrasound-guided percutaneous microwave ablation of thyroid neoplasmProcedure or surgery
Ultrasound-guided percutaneous microwave ablation of thyroid neoplasm
| Study group | Role | What they receive |
|---|---|---|
| Microwave Ablation Group | Active comparator | Patients receive conventional ultrasound-guided microwave ablation. Receives: Procedure: Ultrasound-guided percutaneous microwave ablation of thyroid neoplasm |
| Cryoablation Group | Experimental | Participants undergo ultrasound-guided cryoablation, the investigational treatment evaluated in this study. Receives: Procedure: Ultrasound-guided percutaneous cryoablation of thyroid neoplasm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Volume Reduction Rate (VRR) at 12 months after ablation
Tumor volume is measured by two-dimensional thyroid ultrasound before treatment and at 12-month follow-up. Volume Reduction Rate (%) = (Baseline tumor volume - 12-month ablation zone volume) / Baseline tumor volume × 100%. Compare VRR between microwave ablation group and cryoablation group.
Measured: Baseline (pre-ablation), 12 months after ablation
Secondary outcomes (4)
Complete tumor disappearance rate at 12 months
Complete disappearance is defined as no visible residual lesion and blurred ablation boundary on thyroid ultrasound \& contrast-enhanced ultrasound at 12-month follow-up. Count participants with complete lesion absorption in two groups.
Measured: Baseline, 1, 3, 6, 12 months post-ablation
Incidence of treatment-related complications
Complications include transient hoarseness, hemorrhage, infection, nerve injury, thyroid dysfunction, etc. Divided into minor and major complications according to interventional radiology standard; record all adverse events from procedure to 12-month follow-up.
Measured: Intraoperative, immediate post-op, 1 day, 1, 3, 6, 12 months after ablation
Postoperative pain visual analog scale (VAS) score
Pain scored by VAS (0-10 scale, 0=no pain, 10=worst pain imaginable), assessed at immediate post-procedure and postoperative day 1.
Measured: Immediately after ablation, postoperative day 1
Total operation time
Total procedure duration from puncture to completion of ablation under ultrasound guidance for each participant.
Measured: Intraoperative period only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start9 Feb 2026
- Primary completion10 Jan 2030 (estimated)
- Study completion10 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yukun Luo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yukun Luo, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776262
- Sponsor's protocol ID
- S2025-207-03
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data cannot be shared publicly due to patient privacy protection, institutional data management regulations, and incomplete long-term follow-up data sorting.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Safety and Efficacy of Cryoablation Therapy for Thyroid Tumors
- ClinicalTrials.gov ID
- NCT07776262
- Acronym / sponsor ID
- S2025-207-03
- Conditions
- Thyroid Tumor, Thyroid Neoplasm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Yukun LuoUniversity, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 10 Jan 2030 (estimated)
- Study completion
- 10 Jan 2030 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to learn if cryoablation works to treat thyroid tumors. It will also learn about the safety of cryoablation for thyroid tumors. The main questions it aims to answer are:
- Does cryoablation shrink thyroid tumors over time?
- What side effects or problems do participants have after cryoablation?
Participants will receive cryoablation treatment guided by ultrasound. Researchers will track tumor size changes and check for any safety issues during follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microwave Ablation Group | Active comparator | Procedure: Ultrasound-guided percutaneous microwave ablation of thyroid neoplasmPatients receive conventional ultrasound-guided microwave ablation. |
| Cryoablation Group | Experimental | Procedure: Ultrasound-guided percutaneous cryoablation of thyroid neoplasmParticipants undergo ultrasound-guided cryoablation, the investigational treatment evaluated in this study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 【Group 1: Papillary Thyroid Carcinoma (PTC) patients】
- Pre-operative ultrasound evaluation shows the maximum tumor diameter <1 cm;
- Papillary thyroid carcinoma (PTC) confirmed by ultrasound-guided fine-needle aspiration (FNA) biopsy;
- Solitary PTC confirmed by pre-operative ultrasound;
- Imaging examinations demonstrate no extrathyroidal invasion, cervical lymph node metastasis or distant metastasis.
Key exclusion criteria (7 listed)
- 【Group 1: Papillary Thyroid Carcinoma (PTC) patients】
- (1) Biopsy confirms high-risk subtype papillary thyroid carcinoma; (2) History of thyroid surgery or radiotherapy; (3) Complicated with malignant tumors in other sites; (4) Severe coagulation dysfunction, or patients taking oral anticoagulants who have not reached the required drug-withdrawal period; (5) Incomplete follow-up data. 【Group 2: Benign thyroid nodule patients】
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided percutaneous cryoablation of thyroid neoplasmUnder local anesthesia, ultrasound-guided percutaneous cryoablation is applied to treat thyroid neoplasms. Targeted tumor tissue is destroyed by ultralow temperature from cryoprobes. | Procedure or surgery | Cryoablation Group |
| Ultrasound-guided percutaneous microwave ablation of thyroid neoplasmUltrasound-guided percutaneous microwave ablation of thyroid neoplasm | Procedure or surgery | Microwave Ablation Group |
Primary outcome
Tumor Volume Reduction Rate (VRR) at 12 months after ablation
Time frame: Baseline (pre-ablation), 12 months after ablation
Tumor volume is measured by two-dimensional thyroid ultrasound before treatment and at 12-month follow-up. Volume Reduction Rate (%) = (Baseline tumor volume - 12-month ablation zone volume) / Baseline tumor volume × 100%. Compare VRR between microwave ablation group and cryoablation group.
4 secondary outcomes
Complete tumor disappearance rate at 12 months
Time frame: Baseline, 1, 3, 6, 12 months post-ablation
Incidence of treatment-related complications
Time frame: Intraoperative, immediate post-op, 1 day, 1, 3, 6, 12 months after ablation
Postoperative pain visual analog scale (VAS) score
Time frame: Immediately after ablation, postoperative day 1
Total operation time
Time frame: Intraoperative period only
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No. Data cannot be shared publicly due to patient privacy protection, institutional data management regulations, and incomplete long-term follow-up data sorting.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided percutaneous cryoablation of thyroid neoplasm and Ultrasound-guided percutaneous microwave ablation of thyroid neoplasm in people with Thyroid Tumor and Thyroid Neoplasm, run by Yukun Luo at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yukun Luo, MD (010-66939533, lyk301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Volume Reduction Rate (VRR) at 12 months after ablation (time frame: Baseline (pre-ablation), 12 months after ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.