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

NCT06776588 | Recruiting

• 1 other identifier: Golden staff
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Local contral rate

  LCR is the rate of CR, PR plus SD

  up to 36 months

• Recurrence-free survival

  It estimates the recurrence-free rate of patients who have already survived, with no history of metastasis, a certain period of time.

  up to 36 months

• Overall Survival

  Defined as the time from randomization to death from any cause.

  up to 36 months

Secondary Outcomes (1)

• Detection rate

  up to 36 months

Other Outcomes (2)

• To explore the optimal ablation time

  up to 36 months

• To explore the optimal power selection

  up to 36 months

Study Arms (1)

Microwave ablation combined with biopsy

EXPERIMENTAL

Microwave ablation combined with biopsy

Procedure: Microwave ablation combined with biopsy

Interventions

Microwave ablation combined with biopsy 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.

Microwave ablation combined with biopsy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≤ 75 years;
• GGN patients with the maximum axial diameter of the lesion in the lung window ≤ 3 cm;
• Refusing radical surgery or being unable to tolerate surgical treatment;
• Normal coagulation function, platelet count ≥ 60 × 109 /L;
• ECOG score ≤ 2 points;

You may not qualify if:

• Patients with the maximum axial diameter of the lesion in the lung window greater than 3 cm
• Platelets \<50×109 /L
• Patients with severe bleeding tendency and coagulation dysfunction that cannot be corrected in the short term
• Severe chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis and pulmonary hypertension
• Patients whose anticoagulant therapy or antiplatelet drugs have been discontinued for less than 5 days before ablation
• Patients with severe heart, liver, kidney and brain dysfunction
• Patients with severe anemia, dehydration and cachexia that cannot be corrected or improved in the short term
• Patients with an estimated survival period of less than 6 months

Sponsors & Collaborators

• Beidahuang Industry Group General Hospital: lead

Study Sites (1)

Beidahuang Industry Group General Hospital

Harbin, Heilongjiang, 150088, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Mingyang Liu

CONTACT

86+451 5519 7877; redrumff@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: January 15, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): January 15, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)