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NCT Number: NCT06340945

The Outcomes of Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules

1. To evaluate the clinical outcomes of ultrasound-guided thermal ablationfor the treatment of benign thyroid nodules; 2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of benign thyroid nodules

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Key information

Conditions

Thyroid Nodules Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms Thyroid Nodule

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese PLA General Hospital

Beijing, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • [1]confirmation of benign nodule status on two separate fine- needle aspiration (FNA) or core-needle biopsy (CNB) [2]no suspicious malignant features on ultrasound examination [3]report of cosmetic and/ or symptomatic problems or concern of nodules growing rapidly or malignant transformation [4]refusal or ineligibility for surgery [5]follow-up time ≥6months

Exclusion criteria

  • follicular neoplasm or malignancy findings on biopsy
  • nodules with benign result on biopsy had suspicious of malignancy in US, including marked hypoechoic, ill-defined margins, taller-than-wide shape or microcalcifications
  • patients with cystic nodules
  • patients with contra-lateral vocal cord par- alysis
  • previous radiation to the head and neck
  • ; follow- up time less than 6 months

Treatment and study plan

ultrasound-guided thermal ablation

Procedure

microwave ablation, radio frequency ablation, laser ablation

Primary outcomes

  1. 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

  2. rate of nodule regrowth

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

    Regrowth was defined as ≥50% volume increase compared to the previously recorded smallest volume during the follow-up

Secondary outcomes

  1. rate of complications

    Time frame: 1 week

    complications after ablation

  2. cosmetic score

    Time frame: through study completion, an average of 6 months

    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)

  3. symptom score

    Time frame: through study completion, an average of 6 months

    The symptom score was self-measured by patients using a 10-cm visual analogue scale (grade 0-10)

  4. vital volume

    Time frame: through study completion, an average of 6 months

    vital volume was the incompletely treated vital volume which located peripherally

  5. total volume

    Time frame: through study completion, an average of 6 months

    the overall volume of the nodules

Study contacts

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

Lin Yan, MD.

CONTACT

[email protected]

8613811237313

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

The Clinical Outcomes and Artificial Intelligence Prediction Model of Ultrasound-guided Thermal Ablation for the Treatment of Benign Thyroid Nodules：A Multicenter Prospective Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Apr 2, 2024
Registry last updated
Mar 19, 2026

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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