An interventional study of CassiII rotational core biopsy and Automated biopsy in Peripheral Pulmonary Lesions (PPLs) and Pulmonary Nodules, sponsored by Beijing Chao Yang Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Beijing Chao Yang Hospital · Not applicable, Interventional, and Diagnostic
This study aims to systematically compare the diagnostic efficacy, specimen quality, and complication rates of the cryobiopsy needle technique（CassiII rotational core biopsy） versus the automated biopsy technique in the biopsy of pulmonary nodules, thereby providing a reliable evidentiary basis for clinical practice.
99 studies on the registry are indexed under Multiple Pulmonary Nodules; 42 are open to participants now.
This study's planned enrollment of 308 is above the median of 97 across 46 interventional studies indexed under Multiple Pulmonary Nodules.
Browse Multiple Pulmonary Nodules studies →Beijing Chao Yang Hospital is the lead sponsor of 140 studies on the registry; 49 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
If a chest CT scan reveals pulmonary nodules with an unknown nature, a is required for definitive diagnosis; if the chest CT shows multiple pulmonary nodules, one of these nodules should be selected as the target lesion;
Exclusion Criteria:
Severe cardiopulmonary dysfunction;
Irreversible coagulation disorders;
Suspected vascular lesions or arteriovenous malformations (assessed by contrast-enhanced CT), or presence of bronchial artery penetration at the planned site, or suspected pulmonary from renal cell carcinoma, indicating a high risk of hemorrhage;
PET-CT findings indicate a malignant pulmonary nodule; surgical evaluation may prioritize surgical intervention for the patient;
Pregnant or lactating women; ⑥ Patients with psychiatric disorders or those unable to cooperate during the puncture procedure; ⑦ Presence of anesthesia ; allergy to anesthetic agents; or a history of multiple severe allergies or hereditary allergies;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Under CT guidance, a percutaneous puncture is performed using a coaxial needle; upon reaching the target lesion, the CassiII rotational core biopsy needle is inserted along the coaxial needle for biopsy. At the same lesion site, ≥1 biopsy is performed; depending on sample adequacy, the maximum number of biopsies shall not exceed 3, with at least 1 tissue specimen obtained from each biopsy. Subsequently, the CassiII rotational core biopsy needle and the coaxial needle are withdrawn sequentially. After resting for 5-10 minutes, a repeat CT scan is performed to assess for any complications such as hemorrhage or pneumothorax.
Procedure: CassiII rotational core biopsy
Under CT guidance, a coaxial needle is percutaneously inserted; upon reaching the target lesion, an automated biopsy needle is advanced along the coaxial needle and activated. Biopsy is performed at least once at the same lesion site; depending on sample adequacy, the procedure may be repeated up to a maximum of 3 times, with at least one tissue specimen obtained from each attempt. Subsequently, the automated biopsy needle and the coaxial needle are withdrawn sequentially. After resting for 5-10 minutes, a repeat CT scan is performed to assess for any complications such as hemorrhage or pneumothorax.
Procedure: Automated biopsy
CassiII rotational core biopsy needle is inserted in lesion site, ≥1 biopsy is performed.
Automated biopsy needle is inserted in lesion site, ≥1 biopsy is performed.
Diagnostic yield of the two biopsy methods
Diagnostic yield = (Number of pathologically positive cases / Total number of enrolled cases) × 100%
Time frame: From enrollment to the end of procedure at 2 years
Specimen size
biopsy tissue size (long diameter, millimeter)
Time frame: From enrollment to the end of procedure at 2 years
Consistency analysis between AI-ROSE results and pathological results
The results of AI-ROSE were compared with the pathological results, and the consistency analysis was performed to evaluate the effectiveness of AI-ROSE
Time frame: From enrollment to the end of procedure at 2 years
Safety indicators
Complications: Incidence (including pneumothorax, hemorrhage, respiratory failure, infection, and severe complications requiring endotracheal intubation and mechanical ventilation to be transferred to the Intensive Care Unit), severity levels, and corresponding management measures.
Time frame: From enrollment to the end of procedure at 2 years
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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