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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: Microwave ablation combined with biopsy

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingyang Liu; Phone Number: 86+451 5519 7877; Email: redrumff@163.com

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150088
      • Recruiting
      • Beidahuang Industry Group General Hospital
      • Contact: Mingyang Liu, Director; Phone Number: 0451-55197777; Email: redrumff@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Microwave ablation combined with biopsy

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Defined as the time from randomization to death from any cause.	up to 36 months
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate	The detection rate of early lung cancer was calculated	up to 36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To explore the optimal ablation time	To explore the optimal ablation time	up to 36 months
To explore the optimal power selection	To explore the optimal power selection	up to 36 months

Collaborators and Investigators

• Sponsor: Beidahuang Industry Group General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): January 15, 2028

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Cytological Techniques; Cytodiagnosis; Diagnostic Techniques, Surgical; Biopsy
• Other Study ID Numbers: Golden staff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No