Study on the Diagnosis of Ground-glass Lung Cancer by Microwave Ablation Combined With Puncture Biopsy

NCT ID: NCT06776588

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2028-01-15

Brief Summary

This study is a multicenter study. It plans to screen 200 patients with pulmonary nodule lesions with ground glass as the main body, take CT thin-layer scanning 3D reconstruction, apply AI and fragment omics technology to evaluate the risk of malignant transformation of pulmonary nodules, and use microwave ablation to treat pulmonary nodules and combine intraoperative rapid pathology technology to determine the nature of puncture tissue and the degree of ablation, and then explore the optimal ablation time and ablation power.

Detailed Description

Combining AI and fragmentomics technology, this study enrolled 200 patients with ground-glass lung cancer for comprehensive evaluation. By collecting detailed characteristic data of ground-glass lung cancer, including nodule diameter, average CT value, solid component ratio (CTR), nodule morphology and other related signs, CT imaging and AI technology, and fragmentomics technology were used for comprehensive analysis to form a set of joint strategies to efficiently screen and diagnose patients with early lung cancer.

Microwave ablation is used to treat lung nodules, and intraoperative rapid pathology technology is used to determine the nature of the punctured tissue and the degree of ablation (observing pathological changes in the lesion area, including cancer cell death and fibrosis of the lesion tissue), determine whether the lesion has been completely ablated, or whether there are residual active cancer cells, and then explore the optimal ablation time and ablation power.

Finally, long-term follow-up of patients after microwave ablation, including collection of intraoperative/postoperative complication data, regular CT review, evaluation of treatment effect, monitoring for recurrence, and improving individualized treatment plans for patients.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Microwave ablation combined with biopsy

Microwave ablation combined with biopsy

Group Type: EXPERIMENTAL

Microwave ablation combined with biopsy

Intervention Type: PROCEDURE

CT thin-layer scanning 3D reconstruction is used, and AI and fragment omics technology are used to evaluate the risk of malignant transformation of pulmonary nodules. Microwave ablation of pulmonary nodules is combined with intraoperative rapid pathology technology to determine the nature of punctured tissue and the degree of ablation, and to explore the optimal ablation time and ablation power.

Interventions

Microwave ablation combined with biopsy

CT thin-layer scanning 3D reconstruction is used, and AI and fragment omics technology are used to evaluate the risk of malignant transformation of pulmonary nodules. Microwave ablation of pulmonary nodules is combined with intraoperative rapid pathology technology to determine the nature of punctured tissue and the degree of ablation, and to explore the optimal ablation time and ablation power.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age ≤ 75 years;

2. GGN patients with the maximum axial diameter of the lesion in the lung window ≤ 3 cm;

3. Refusing radical surgery or being unable to tolerate surgical treatment;

4. Normal coagulation function, platelet count ≥ 60 × 109 /L;

5. ECOG score ≤ 2 points;

Exclusion Criteria

1. Patients with the maximum axial diameter of the lesion in the lung window greater than 3 cm

2. Platelets <50×109 /L

3. Patients with severe bleeding tendency and coagulation dysfunction that cannot be corrected in the short term

4. Severe chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis and pulmonary hypertension

5. Patients whose anticoagulant therapy or antiplatelet drugs have been discontinued for less than 5 days before ablation

6. Patients with severe heart, liver, kidney and brain dysfunction

7. Patients with severe anemia, dehydration and cachexia that cannot be corrected or improved in the short term

8. Patients with an estimated survival period of less than 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beidahuang Industry Group General Hospital

OTHER

Sponsor Role: lead

Responsible Party

LiuMingyang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beidahuang Industry Group General Hospital

Harbin, Heilongjiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mingyang Liu

Role: CONTACT

redrumff@163.com

86+451 5519 7877

Facility Contacts

Mingyang Liu, Director

Role: primary

redrumff@163.com

0451-55197777

Other Identifiers

Golden staff

Identifier Type: -

Identifier Source: org_study_id