NCT07232433Recruiting
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
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 27 Sept 2025
- Start date
- 21 Nov 2025
- Primary completion date
- 1 Oct 2028
- Lead sponsor
- Ruijin Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07232433
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 21 Nov 2025 to the primary completion date, 1 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another interventional clinical trial, or anticipation of requiring additional antitumor therapy outside the scope of this study during the trial period.
Other illness
- Presence of severe cardiac, pulmonary, hepatic, or renal dysfunction, rendering the patient ineligible for general anesthesia.
- Any other condition deemed by the investigator to render the patient unsuitable for study participation.
Lab values
- Platelet count \< 50 × 10⁹/L, or presence of an uncorrectable bleeding diathesis or coagulation disorder (prothrombin time \> 18 seconds, or prothrombin activity \< 40%).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.