Cryoablation treatment for pulmonary ground-glass nodules

Safety and Efficacy Evaluation of Cryoablation for Ground-Glass Nodules: A Single-Arm, Prospective, Open-Label Clinical Study

This will try cryoablation as a less-invasive treatment for adults with small malignant ground-glass nodules who cannot or choose not to have surgery or radiotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT07232433 on ClinicalTrials.gov

What this trial studies

This single-center interventional study tests percutaneous or bronchoscopic cryoablation to destroy pulmonary ground-glass nodules (GGNs) measuring 6–30 mm in patients with confirmed malignancy who are ineligible for or decline VATS or radiotherapy. The procedure uses ultra-low temperatures to create a well-defined ablation zone while aiming to preserve surrounding lung tissue and reduce procedural pain. Eligible patients may have a solitary GGN or up to three nodules judged treatable by a multidisciplinary team, and procedures are performed under image guidance with follow-up to monitor safety and local tumor control. The trial is led by Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and focuses on short-term safety and longer-term efficacy outcomes for cryoablation in this population.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically confirmed or MDT-confirmed malignant GGNs 6–30 mm (solitary or up to three treatable nodules), ECOG 0–1, who are ineligible for or decline VATS and radiotherapy and can tolerate the procedure.

Not a fit: Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction preventing anesthesia, contraindications to CT-guided percutaneous puncture or bronchoscopy, or lesions judged high-risk for puncture are unlikely to benefit.

Why it matters

Potential benefit: If successful, cryoablation could offer a less-invasive option that controls early malignant GGNs while preserving lung function for patients who cannot have or decline surgery or radiation.

How similar studies have performed: Small case series and observational reports have shown cryoablation can achieve local control for pulmonary nodules, but high-quality, long-term data specifically for GGNs remain limited.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years.
* Malignancy confirmed by histopathology or multidisciplinary team (MDT) discussion.

For a solitary GGN: size between 6-30 mm. For multiple GGNs: each measuring 6-30 mm, with no more than 3 nodules deemed to require treatment upon MDT consensus.

* Patient is ineligible for or unwilling to undergo video-assisted thoracoscopic surgery (VATS).
* Patient is ineligible for or declines radiotherapy or stereotactic body radiotherapy (SBRT).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* The subject demonstrates good compliance and has voluntarily provided written informed consent to participate.

Exclusion Criteria:

* Presence of severe cardiac, pulmonary, hepatic, or renal dysfunction, rendering the patient ineligible for general anesthesia.
* Contraindication to either bronchoscopy or computed tomography (CT)-guided percutaneous puncture.
* High risk associated with percutaneous puncture for at least one target lesion, or absence of a feasible access route as determined by pre-procedural bronchoscopic path planning.
* Platelet count \< 50 × 10⁹/L, or presence of an uncorrectable bleeding diathesis or coagulation disorder (prothrombin time \> 18 seconds, or prothrombin activity \< 40%).
* Concurrent participation in another interventional clinical trial, or anticipation of requiring additional antitumor therapy outside the scope of this study during the trial period.
* Any other condition deemed by the investigator to render the patient unsuitable for study participation.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Hecheng Li

Conditions Lung Cancer