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NCT06316895 Clinical Trial

The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma

Papillary Thyroid Cancer Clinical Trial

Official title:
The Clinical Outcomes and Artificial Intelligence Prediction Model of Ultrasound-guided Thermal Ablation for the Treatment of Low-risk Papillary Thyroid Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06316895
Other study ID # S2023-706
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date December 31, 2029

Study information
Verified date March 2024
Source Chinese PLA General Hospital
Contact Lin Yan, MD
Phone 13811237313
Email gemma-y@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1. To evaluate the clinical outcomes of ultrasound-guided thermal ablation and thyroid surgery for the treatment of papillary thyroid carcinoma; 2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of papillary thyroid carcinoma;

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 3772
Est. completion date December 31, 2029
Est. primary completion date April 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. patients age between 18 and 80 year old, both sex 2. papillary thyroid carcinoma confirmed by core-needle biopsy or fine-needle aspiration 3. the largest diameter =2.0 cm 4. no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, nech and chest CT 5. follow-up period =12 months, Exclusion Criteria: 1. patients with convincing evidence of aggressive papillary thyroid carcinoma or other type of thyroid cancer by biopsy 2. history of neck radiation 3. history of thyroid surgery 4. coagulation disorder 5. serious heart, respiratory, liver, or renal failure 6. dysfunction of the vocal cord on the opposite side

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• thyroid surgery
thyroid lobectomy
• ultrasound-guided thermal ablation
radiofrequency ablation; microwave ablation or laser ablation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Chinese PLA General Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary rate of disease progression cervical lymph node metastases, recurrent tumors and persistent tumors more than 5 year
Secondary Rate of complications surgery or ablation complications 1week
Secondary Rate of tumor disappearance complete disappearance of ablated tumor on ultrasound and contrast-enhanced ultrasound 2 year
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