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NCT Number: NCT06776588

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beidahuang Industry Group General Hospital

Harbin, Heilongjiang, 150088, China

Location status: Recruiting

Location contact

Mingyang Liu, Director

CONTACT

[email protected]

0451-55197777

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Local contral rate

    Time frame: up to 36 months

    LCR is the rate of CR, PR plus SD

  2. Recurrence-free survival

    Time frame: up to 36 months

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

  3. Overall Survival

    Time frame: up to 36 months

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

Secondary outcomes

  1. Detection rate

    Time frame: up to 36 months

    The detection rate of early lung cancer was calculated

Other outcomes

  1. To explore the optimal ablation time

    Time frame: up to 36 months

    To explore the optimal ablation time

  2. To explore the optimal power selection

    Time frame: up to 36 months

    To explore the optimal power selection

Study contacts

Contact information is provided by the study sponsor or research team.

Mingyang Liu

CONTACT

[email protected]

86+451 5519 7877

Sponsors and collaborators

Lead sponsor

Beidahuang Industry Group General Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 15, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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