Cryoablation treatment for pulmonary ground-glass nodules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting
• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Hecheng Li
• Email: lihecheng2000@hotmail.com
• Phone: 021-021-64370045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.