Pulmonary Nodules
Conditions
Keywords
Pulmonary nodule, Cryoablation, Transthoracic biopsy, Lung cancer
Brief summary
This prospective, single-center clinical study will evaluate whether an 18-gauge ultrafine cryoablation needle can be used feasibly and safely during CT-guided coaxial transthoracic biopsy of pulmonary nodules. Approximately 30 adults with pulmonary nodules highly suspected of malignancy who are unsuitable for or decline surgery or radiotherapy will undergo biopsy and cryoablation during the same procedure. The study will assess technical success, biopsy diagnostic performance, imaging-based local control, and device- or procedure-related adverse events. Participants will be followed for up to 36 months. The study hypothesis is that the same-tract procedure is technically feasible and provides acceptable safety and local disease control.
Detailed description
All participants will be assigned to a single intervention group. Under CT guidance, a coaxial needle will be positioned near the pulmonary nodule. Biopsy specimens will be obtained before cryoablation. An 18G ultrafine cryoablation needle will then be introduced through the same coaxial tract, and image-guided cryoablation will be performed according to lesion size, shape, and location. A second biopsy may be obtained after ablation. Staged or supplemental ablation is allowed when clinically required. Follow-up assessments include chest CT, safety evaluation, and long-term disease and survival follow-up for up to 36 months.
Interventions
DEVICE18G Ultrafine Cryoablation Needle
An ultrafine cryoablation needle used for image-guided local ablation of pulmonary nodules. Treatment parameters are individualized according to lesion characteristics.
Sponsors
Shanghai Chest Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older. * One or more pulmonary nodules measuring 3 cm or less on chest CT and considered highly suspicious for malignancy after multidisciplinary review. * The participant is unsuitable for or declines surgery and radiotherapy after multidisciplinary evaluation and shared decision-making. * A safe percutaneous access route is available, and the planned ablation zone can cover the target lesion. * Eastern Cooperative Oncology Group performance status of 0 to 2. * Expected survival of at least 12 months. * The participant or legally authorized representative voluntarily provides written informed consent.
Exclusion criteria
* Platelet count below 50 × 10\^9/L, clinically significant bleeding tendency, or uncorrectable coagulation disorder. * Severe pulmonary fibrosis, pulmonary hypertension, or other severe cardiac, pulmonary, hepatic, renal, neurologic, or systemic organ dysfunction that makes the procedure unsafe. * Uncontrolled local or systemic infection, including uncontrolled infection near the lesion or access site, or fever above 38.5°C. * Poorly controlled malignant pleural effusion. * Anticoagulant or antiplatelet therapy cannot be safely managed before the procedure according to institutional policy. * Pregnancy or a plan to become pregnant during the study. * Active serious psychiatric illness that may interfere with informed consent or study participation. * Participation in another clinical study within 30 days before enrollment. * Any other condition that, in the investigator's judgment, makes participation inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success rate | Procedure day | Percentage of treated target lesions for which immediate post-ablation imaging shows an ablation zone extending at least 5 mm beyond the target lesion boundary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | 1 months | Percentage of biopsied lesions yielding a diagnostic histopathologic result |
| Biopsy specimen quality | 1 months | Comparison of pre-ablation and post-ablation specimens using specimen quality with a modified 5-point Likert scale (point 0-4, The higher the score, the better the sample quality.) |
| Complete ablation rate | Months 3, 6, and 12 | Percentage of treated lesions meeting the protocol-defined imaging criteria for complete ablation. |
| Local control rate | Months 12, 24, and 36 | Percentage of treated lesions without local progression at each scheduled time point. |
| Progression-free survival | Up to 36 months | Time from the study procedure to the first documented disease progression or death from any cause. |
| Overall survival | Up to 36 months | Time from the study procedure to death from any cause. |
| Device- or procedure-related adverse events | From the procedure through Month 12 | Incidence of adverse events assessed by the investigator as related to the device or study procedure |
Contacts
CONTACTJiayuan Sun
Outcome results
None listed