Navigational bronchoscopy-guided cryoablation for small lung tumors

An Exploratory Clinical Trial Evaluating Navigational Bronchoscopy System and Bronchoscope and Accessories in Combination With Cryoablation Therapy Device for the Treatment of Lung Malignancies

This trial will try using a navigation-guided bronchoscope plus cryoablation to treat small peripheral lung cancers in people who cannot or choose not to have surgery or radiotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Tianjin Puli Ark Medical Technology Co., Ltd. (Academic / other)
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT07301411 on ClinicalTrials.gov

What this trial studies

This is a prospective, dual-center exploratory trial enrolling about 40 adults to test navigational bronchoscopy systems combined with cryoablation for lung malignancies. Participants are treated on Day 0 with a navigational bronchoscopy and bronchoscope plus cryoablation device using one of two device cohorts and are followed for safety and effectiveness. Follow-up visits are scheduled at 24 hours, about 1 month, and about 3 months after treatment, with additional data collected up to 12 months as part of routine care. Eligible lesions are peripheral, ≤3 cm in diameter, up to three tumors, and subjects are aged 18–80 who decline or are unsuitable for surgery or radiotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults 18–80 with primary peripheral stage IA lung cancer or limited metastatic lung tumors with lesions ≤3 cm and ≤3 tumors that are judged reachable by bronchoscopy and who decline or are unsuitable for surgery or radiotherapy.

Not a fit: Patients with diffuse bilateral lung disease, tumors larger than 3 cm, centrally located lesions not accessible by bronchoscopy, or lesions judged infeasible for bronchoscopic ablation are unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, this approach could offer a minimally invasive option to destroy small peripheral lung tumors while avoiding or delaying surgery or external radiation.

How similar studies have performed: Small early-phase studies of bronchoscopic tumor ablation techniques have shown proof-of-concept and feasibility, but larger controlled data are still limited.

Eligibility criteria

Inclusion Criteria:

1. Aged 18 to 80 years old (inclusive), male or female;
2. Primary peripheral lung cancer, with pre-treatment staging examination indicating clinical stage T1N0M0, IA (including new onset and multiple primary lesions after treatment); or metastatic lung tumor, with the primary lesion completely removed or well controlled;
3. The maximum diameter of the tumor is ≤3 cm;
4. The number of tumors is ≤3 (no limit for multiple primary lung cancer subjects);
5. Subjects who decline or are deemed unsuitable for surgery per multidisciplinary team's discretion;
6. Subjects who decline or are deemed unsuitable for radiotherapy per investigator's discretion;
7. Subjects whose lesions to be ablated are assessed to be feasible for bronchoscopy-guided cryoablation per investigator's discretion;
8. Subjects who are willing to participate in the study and sign the written informed consent.

Exclusion Criteria:

1. Subjects with diffuse lesions in both lungs whose condition cannot be improved by ablation treatment;
2. Subjects whose examination within 1 month prior to treatment suggests intrathoracic lymph node metastasis or extrapulmonary metastasis (except for those whose extrapulmonary metastasis is controlled by local treatment);
3. With reference to the Guidelines for the Application of Diagnostic Flexible Bronchoscopy for Adults (2019 Edition) \[1\], subjects with contraindications for bronchoscopy, such as acute myocardial infarction (within 4 weeks), active massive hemoptysis, platelet count \< 60×109/L, malignant arrhythmia, unstable angina, severe cardiopulmonary insufficiency, hypertensive crisis, severe pulmonary hypertension, intracranial hypertension, acute cerebrovascular events (i.e. cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, intracranial venous thrombosis, etc.), aortic dissection, aortic aneurysm, and systemic extreme failure;
4. Subjects who are using antiplatelet or anticoagulant drugs and cannot be properly managed before treatment (properly managed including clopidogrel terminated 7 days before treatment, ticagrelor terminated 5 days before treatment, warfarin terminated 5 days before treatment, low molecular weight heparin terminated 24 hours before treatment, etc.);
5. Subjects with severe bleeding tendency, uncorrectable coagulation dysfunction;
6. Subjects with electrically or magnetically activated devices implanted or metallic implants (non-titanium);
7. Subjects with other tumors and extensive metastasis, with an expected survival of less than 12 months;
8. Poor general condition (e.g. systemic multiple metastases, severe infection, high fever), infectious and radioactive inflammation around the focus, obvious cachexia, serious dysfunction of important organs, severe anemia and nutritional metabolism disorder that cannot be improved in a short time;
9. The subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of \>2 (See Appendix 1 for details of ECOG scoring criteria);
10. Subjects having received radiotherapy within the past 6 months for the lesion to be ablated;
11. Subjects expected to participate in any other experimental or invasive clinical study within 12 months of the ablation procedure;
12. Subjects with a history of active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) infection (known HIV1/2 antibody positive) or, in the investigator's judgment, conditions that may affect the subject's treatment;
13. Those with epilepsy, psychiatric history or cognitive impairment;
14. Pregnant, lactating women, and subjects who are unwilling to use reasonable contraception during the clinical trial;
15. Subjects who had participated or are participating in a drug clinical trial within 3 months (participants in non-interventional trials can be included), or who had participated or are participating in another medical device clinical trial within 1 month (participants in non-interventional trials can be included);
16. Other circumstances which are considered by the investigator not suitable for participation in the study.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Chinese University of Hong Kong, Prince of Wales Hospital — Shatin, Hong Kong (Not_yet_recruiting)

Study contacts

• Principal investigator: Jiayuan Sun — Shanghai Chest Hospital
• Study coordinator: Dandan Jia

Conditions Lung Malignancies; Navigational Bronchoscopy System; Cryoablation