Thyroid Nodule (Benign)NCT06729762
Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules
An observational study of Thyroid Nodule (Benign), run by Chinese PLA General Hospital at 1 site in China.
Trial summary
To evaluate long-term outcomes of ultrasound-guided thermal ablation for benign thyroid nodules Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule (Benign)
- What is being tested?
- ultrasound-guided thermal ablation
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2024to 31 Dec 2030
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with thyroid nodules
Who may be able to join
- confirmation of benign nodule status on two separate fine- needle aspiration or core-needle biopsy
- no suspicious malignant features on ultrasound examination
- report of cosmetic and/ or symptomatic problems or concern of nodules growing rapidly or malignant transformation
- refusal or ineligibility for surgery
- follow-up time ≥12 months
Who cannot join
- follicular neoplasm or malignancy findings on biopsy
- nodules with benign result on biopsy had suspicious of malignancy in US
- patients with contra-lateral vocal cord paralysis
- previous radiation to the head and neck
- follow- up time less than 12 months
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 PLA General Hospital
Beijing, Beijing Municipality, 100853
Lin Yan
Lin Yan
About this study
Official title: Ultrasound-guided Thermal Ablation for the Treatment of Benign Thyroid Nodules: A Multicenter Study
To evaluate long-term outcomes of ultrasound-guided thermal ablation for benign thyroid nodules
Read the detailed description
To evaluate and predict long-term clinical outcomes of ultrasound-guided thermal ablation for benign thyroid nodules by a multicenter study
- Conditions
- Thyroid Nodule (Benign)
- Being tested
- ultrasound-guided thermal ablation
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided thermal ablationProcedure or surgery
radiofrequency ablation, microwave ablation, laser ablation
| Study group | Role | What they receive |
|---|---|---|
| ultrasound-guided thermal ablation | ultrasound-guided thermal ablation Receives: Procedure: ultrasound-guided thermal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume reduction rate
The volume reduction rate (VRR)was calculated by the equations: VRR=([initial volume-final volume] × 100)/initial volume
Measured: through study completion, an average of 6 months
Secondary outcomes (6)
rate of complications
complications after ablation
Measured: 1 week
cosmetic score
The cosmetic score was assessed by a physician (1, no palpable mass; 2, no cosmetic problem but palpable mass; 3, a cosmetic problem on swallowing only; and 4, a readily detected cosmetic problem)
Measured: through study completion, an average of 6 months
symptom score
The symptom score was self-measured by patients using a 10-cm visual analogue scale (grade 0-10)
Measured: through study completion, an average of 6 months
rate of nodule regrowth
Regrowth was defined as ≥50% volume increase compared to the previously recorded smallest volume during the follow-up
Measured: through study completion, an average of 6 months
rate of change of thyroid function
thyroid function test, including free triiodothyronine, free thyroxine, thyroid stimulating hormone, thyroid peroxidase antibody and anti-thyroglobulin antibodies
Measured: through study completion, an average of 6 months
rate of disappearance
complete disappearance of ablated nodule on ultrasound and contrast-enhanced ultrasound
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start9 Dec 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Nodule (Benign)Studies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-kun Luo, Chinese PLA General Hospital
- Investigators
- Yukun Luo, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729762
- Sponsor's protocol ID
- 2024-654
- Status last verified
- Feb 2025
- First submitted
- 7 Dec 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Thermal Ablation for the Treatment of Benign Thyroid Nodules: A Multicenter Study
- ClinicalTrials.gov ID
- NCT06729762
- Acronym / sponsor ID
- 2024-654
- Conditions
- Thyroid Nodule (Benign)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 11 Dec 2024 (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.
To evaluate long-term outcomes of ultrasound-guided thermal ablation for benign thyroid nodules
Detailed description
To evaluate and predict long-term clinical outcomes of ultrasound-guided thermal ablation for benign thyroid nodules by a multicenter study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound-guided thermal ablation | – | Procedure: ultrasound-guided thermal ablationultrasound-guided thermal ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with thyroid nodules
Key inclusion criteria (5 listed)
- confirmation of benign nodule status on two separate fine- needle aspiration or core-needle biopsy
- no suspicious malignant features on ultrasound examination
- report of cosmetic and/ or symptomatic problems or concern of nodules growing rapidly or malignant transformation
- refusal or ineligibility for surgery
- follow-up time ≥12 months
Key exclusion criteria (5 listed)
- follicular neoplasm or malignancy findings on biopsy
- nodules with benign result on biopsy had suspicious of malignancy in US
- patients with contra-lateral vocal cord paralysis
- previous radiation to the head and neck
- follow- up time less than 12 months
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 thermal ablationradiofrequency ablation, microwave ablation, laser ablation | Procedure or surgery | ultrasound-guided thermal ablation |
Primary outcome
volume reduction rate
Time frame: through study completion, an average of 6 months
The volume reduction rate (VRR)was calculated by the equations: VRR=([initial volume-final volume] × 100)/initial volume
6 secondary outcomes
rate of complications
Time frame: 1 week
cosmetic score
Time frame: through study completion, an average of 6 months
symptom score
Time frame: through study completion, an average of 6 months
rate of nodule regrowth
Time frame: through study completion, an average of 6 months
rate of change of thyroid function
Time frame: through study completion, an average of 6 months
rate of disappearance
Time frame: through study completion, an average of 6 months
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 14 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Yukun Luo principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodule (Benign), run by Chinese PLA General Hospital 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 5 inclusion and 5 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 14 Feb 2025. 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 Lin Yan, MD (13811237313 ext. 86, gemma-y@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume reduction rate (time frame: through study completion, an average of 6 months). 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 14 Feb 2025.