Clinical trial NCT06776588: Study on the Diagnosis of Ground-glass Lung Cancer by Microwave Ablation Combined With Puncture Biopsy
Official title: Study on the Diagnosis of Ground-glass Lung Cancer by Microwave Ablation Combined With Puncture Biopsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Beidahuang Industry Group General Hospital
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Local contral rate
timeFrame: up to 36 months
measure: Recurrence-free survival
timeFrame: up to 36 months
measure: Overall Survival
timeFrame: up to 36 months
Secondary outcomes:
measure: Detection rate
timeFrame: up to 36 months
Other outcomes:
measure: To explore the optimal ablation time
timeFrame: up to 36 months
measure: To explore the optimal power selection
timeFrame: up to 36 months
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