CT-guided Microwave Ablation in Ground Glass Nodules

NCT ID: NCT03652350

Last Updated: 2018-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-13
• Study Completion Date: 2019-02-28

Brief Summary

In order to conduct a multicenter comparative effectiveness clinical research of phase II to investigate safety and efficacy of applying microwave ablation in patients with Great-glass lung nodules ≤ 3cm, a single center, non-randomized, open label pilot study is conducted to examine the flexibility, safety and efficacy of using Microwave Ablation in Patients with Ground Glass Nodules that are poor candidate of surgery.

Detailed Description

Lung cancer is the most common cancer worldwide contributing 13% of the total number of new cases diagnosed. The main treatments of lung cancer are based on surgical resection and adjuvant postoperative chemotherapy. However, the patients who are intolerant of surgery wouldn't be benefit from surgical resection. Microwave ablation provide new choice for lung cancer, which can effectively treat early lung cancer. The diagnosis of early lung cancer can be based on the results of biopsy of ground-glass nodules (GGNs), which is one of the diagnostic criteria for preoperative diagnosis of early lung cancer. The microwave ablation is the good choice for patients who cannot tolerate surgical resection. However, the flexibility, safety and efficacy of using Microwave Ablation in Patients with Ground Glass Nodules are still unclear.

Conditions

Ground Glass Nodules Less Than 3cm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Use CT-guided microwave ablation in Ground Glass Nodules ≤ 3cm

Patients with Ground Glass Nodules ≤ 3cm were treated with CT-guided microwave ablation

Group Type: EXPERIMENTAL

CT-guided microwave ablation

Intervention Type: PROCEDURE

Using thermal ablation electrode ECO-100AL6 probe target the GGN zone with the guidance performed by CT (Bright Speed Scanner )

Interventions

CT-guided microwave ablation

Using thermal ablation electrode ECO-100AL6 probe target the GGN zone with the guidance performed by CT (Bright Speed Scanner )

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent, inclusive of release of medical information.

2. Age ≥ 18 years

3. CT scan indicates presence of Ground Glass Lung Nodules less than 30mm

4. Willing to comply with all protocol required follow-up: 30 days and 90 days post microwave ablation

5. Patients who cannot tolerate surgical resection due to cardiopulmonary dysfunction and advanced age

6. Patients who refuse surgical resection

7. Patients who don't have serious complications

Exclusion Criteria

1. Unable to give informed consent or potential for noncompliance with the study protocol in the judgement of the investigator

2. Pregnant or breast-feeding at time of screening

3. Active skin infection and ulceration around the percutaneous site

4. Severe pulmonary fibrosis, especially drug-induced pulmonary fibrosis

5. Tendency of severe bleeding, platelets less than 50 × 109 / L and severe blood coagulation disorders. Anticoagulant therapy and/or antiplatelet agents should be discontinued for at least 5d-7d before microwave ablation.

6. Ablation of the ipsilateral malignant pleural effusion is not well controlled

7. Liver, kidney, heart, lung, brain dysfunction, severe anemia, dehydration and serious disorders of nutritional metabolism, cannot be corrected or improved in the short term, severe systemic infection, high fever (> 38.5 oC)

8. Extensive extrapulmonary metastasis, expected to survive < 3 months

9. Eastern Cooperative Oncology Group (ECOG) performance status > 3

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuxi People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wuxi People's Hospital

Wuxi, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian Bao, MD

Role: CONTACT

13358119776@189.cn

13358119776

Peihua Lu, MD

Role: CONTACT

13621500031@189.cn

13621500031

Facility Contacts

Jian Bao, MD

Role: primary

13358119776@189.cn

13358119776

Peihua Lu, MD

Role: backup

13621500031@189.cn

13621500031

Other Identifiers

KYLLH2018039

Identifier Type: -

Identifier Source: org_study_id