NCT07232433

Safety and Efficacy Evaluation of Cryoablation in the Treatment of Ground-Glass Nodules

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Lung cancer is the leading cause of cancer-related mortality worldwide, making early diagnosis and intervention critical. With the widespread adoption of low-dose computed tomography (LDCT) screening, the detection rate of pulmonary ground-glass nodules (GGNs) has increased significantly. Although video-assisted thoracoscopic surgery (VATS) remains the standard treatment for early-stage lung cancer, a considerable proportion of patients are ineligible for surgery due to advanced age, impaired cardiopulmonary function, or multiple nodules. Cryoablation, a minimally invasive ablation technique, uses ultra-low temperatures to induce tumor cell death. It offers distinct advantages, including well-defined ablation margins, reduced procedural pain, preservation of adjacent healthy structures, and potential immune activation, providing an important alternative for this patient population. However, the safety and long-term efficacy of cryoablation for GGNs require further high-quality clinical evidence. This study aims to conduct a prospective, single-center, open-label clinical trial to systematically evaluate the feasibility and outcomes of cryoablation (percutaneous or electromagnetic navigation bronchoscopy \[ENB\]-guided) for treating pulmonary GGNs. We plan to enroll 90 patients who meet the following criteria: pathologically or multidisciplinary team (MDT)-confirmed malignancy, GGN size ranging from 6-30 mm, solid component ratio \<25%, unsuitability for or refusal of surgery/radiotherapy, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. The primary endpoint is the 2-year local recurrence rate after ablation. Secondary endpoints include the 5-year local recurrence rate, 3- and 5-year disease-free survival (DFS) rates, technical success rate (ablation completion), perioperative complications (e.g., pneumothorax, hemorrhage, infection), postoperative pulmonary function, pain scores, length of hospital stay, and treatment-related costs. The results of this study will provide critical clinical evidence to support the use of cryoablation for GGNs, optimize patient selection criteria, and promote the advancement of this minimally invasive technique.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	Cryoablation	Following enrollment, patients will undergo comprehensive preoperative evaluations, including thoracic computed tomography (CT), echocardiography, pulmonary function tests, electrocardiography, and laboratory blood tests, to confirm eligibility and exclude any contraindications. Eligible patients will be admitted for cryoablation, performed either percutaneously or under electromagnetic navigation bronchoscopy (ENB) guidance, followed by a structured postoperative follow-up regimen.

Timeline

• Start date: 2025-11-21
• Primary completion: 2028-10-01
• Completion: 2030-10-01
• First posted: 2025-11-18
• Last updated: 2026-01-22

Locations

2 sites across 1 country: China