One-stop Diagnosis and Treatment for Suspected Lung Cancer: Combined RBS, nClE, OBCT and Ablation (NCT07521618) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
One-stop Diagnosis and Treatment for Suspected Lung Cancer: Combined RBS, nClE, OBCT and Ablation
30 participantsStarted 2026-04-01
Plain-language summary
Using RBS as the navigation and treatment platform, precisely navigate to the target lesion. Utilize r-EUBS and nCLE to identify the lesion, and when the confocal AI model recognizes the lesion as malignant, perform a biopsy. Subsequently, under the guidance of OBCT, carry out ablation treatment of the lesion.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years, male or female.
* High-risk pulmonary nodule/tumor maximum diameter ≤3 cm.
* Lesion judged suitable for bronchial navigation-guided diagnosis and treatment.
* Ineligible for surgery or refuses surgery/radiotherapy; agrees to primary ablation therapy; provides written informed consent.
Exclusion Criteria:
* Diffuse bilateral lung lesions unresponsive to ablation.
* Contraindication to bronchoscopy or inability to tolerate/cooperate with bronchoscopy.
* Severe bleeding tendency or irreversible coagulopathy (PT \>18 s, PTA \<40%).Platelet count \<70×10⁹/L; anticoagulant/antiplatelet therapy discontinued \<1 week before ablation (except prophylactic low-molecular-weight heparin).
* Severe pulmonary impairment (maximal voluntary ventilation \<40%).
* Other metastatic tumors with widespread metastasis; life expectancy \<3 months.
* Poor general condition: widespread metastasis, severe infection, high fever, infectious/radiation inflammation around the lesion, obvious cachexia, severe organ dysfunction, severe anemia, uncorrectable metabolic/nutritional disorders.
* Eastern Cooperative Oncology Group (ECOG) performance status \>2.
* Target lesion received radiotherapy within the past 6 months.
* Active hepatitis B, active hepatitis C, known HIV-1/2 antibody positivity, or other active infections judged by the investigator to interfere with treatment.
* History of epilepsy, psychosis, or cognitive impairment.
* Pregnant/lactating females; males…
What they're measuring
1
Integrated completion rate of detection, sampling and treatment
Timeframe: Day 1 (when the procedure was completed and a CBCT scan was conducted to determine the ablation range)