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

NCT07232433 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-01-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-21
Primary Completion
2028-10-01
Completion
2030-10-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07232433 on ClinicalTrials.gov