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

Thyroid Nodules Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06340945
• Other study ID #: S2023-761-01
• Status: Not yet recruiting
• Phase: N/A
• 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: 8613811237313
• Email: gemma-y[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. follicular neoplasm or malignancy findings on biopsy

2. nodules with benign result on biopsy had suspicious of malignancy in US, including marked hypoechoic, ill-defined margins, taller-than-wide shape or microcalcifications

3. patients with cystic nodules

4. patients with contra-lateral vocal cord par- alysis

5. previous radiation to the head and neck

6. ; follow- up time less than 6 months

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule
• Thyroid Nodules

Intervention

Procedure:
• ultrasound-guided thermal ablation
microwave ablation, radio frequency ablation, 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	volume reduction rate	The volume reduction rate (VRR)was calculated by the equations: VRR=([initial volume-final volume] × 100)/initial volume	through study completion, an average of 6 months
Primary	rate of nodule regrowth	Regrowth was defined as =50% volume increase compared to the previously recorded smallest volume during the follow-up	through study completion, an average of 1 months
Secondary	rate of complications	complications after ablation	1 week
Secondary	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)	through study completion, an average of 6 months
Secondary	symptom score	The symptom score was self-measured by patients using a 10-cm visual analogue scale (grade 0-10)	through study completion, an average of 6 months
Secondary	vital volume	vital volume was the incompletely treated vital volume which located peripherally	through study completion, an average of 6 months
Secondary	total volume	the overall volume of the nodules	through study completion, an average of 6 months