Lung CancerNCT06776588
Study on the Diagnosis of Ground-glass Lung Cancer by Microwave Ablation Combined With Puncture Biopsy
A study testing Microwave ablation combined with biopsy in people with Lung Cancer, run by Beidahuang Industry Group General Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Microwave ablation combined with biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2025to 15 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beidahuang Industry Group General Hospital
Harbin, Heilongjiang, 150088
Mingyang Liu, Director, 0451-55197777, redrumff@163.com
About this study
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.
Read the 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
- Being tested
- Microwave ablation combined with biopsy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave ablation combined with biopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Microwave ablation combined with biopsy | Experimental | Microwave ablation combined with biopsy Receives: Procedure: Microwave ablation combined with biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local contral rate
LCR is the rate of CR, PR plus SD
Measured: 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.
Measured: up to 36 months
Overall Survival
Defined as the time from randomization to death from any cause.
Measured: up to 36 months
Secondary outcomes (1)
Detection rate
The detection rate of early lung cancer was calculated
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start15 Jan 2025
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beidahuang Industry Group General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LiuMingyang, Beidahuang Industry Group General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776588
- Sponsor's protocol ID
- Golden staff
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Diagnosis of Ground-glass Lung Cancer by Microwave Ablation Combined With Puncture Biopsy
- ClinicalTrials.gov ID
- NCT06776588
- Acronym / sponsor ID
- Golden staff
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beidahuang Industry Group General HospitalUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microwave ablation combined with biopsy | Experimental | Procedure: Microwave ablation combined with biopsyMicrowave ablation combined with biopsy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave ablation combined with biopsyCT 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. | Procedure or surgery | Microwave ablation combined with biopsy |
Primary outcome
Local contral rate
Time frame: up to 36 months
LCR is the rate of CR, PR plus SD
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.
Overall Survival
Time frame: up to 36 months
Defined as the time from randomization to death from any cause.
1 secondary outcome
Detection rate
Time frame: up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave ablation combined with biopsy in people with Lung Cancer, run by Beidahuang Industry Group General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingyang Liu (86+451 5519 7877, redrumff@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local contral rate (time frame: up to 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.