Microwave Ablation in Ground Glass Nodules

Shandong First Medical University

Status and phase: Not yet enrolling; Phase 2

Conditions: Lung Cancer; Microwave Ablation

Treatments: Other: Microwave ablaton

Study type: Interventional

Funder types: Other

Identifiers

NCT03490890

Shandong PH JN

Details and patient eligibility

About

GGO was commonly observed recently.Radiofrequency ablation has been widely applied in the treatment of patients with GGO. No study had explored the microwave ablation in the treatment of GGO.

Full description

GGO was common with the development of image. Treatments of GGO include radical surgery and irradiation. For patients who were poor candidate of surgery, image guided thermal ablation could be an alternative.Radiofrequency ablation has been widely applied in the treatment of eary-stage non small cell lung cancer and those patients with GGO. However, up to date, no study had explored the microwave ablation in the treatment of GGO.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient has a histologically verified AIS or MIA.
2. The tumors small enough to treat (usually ≤3 cm), and without chest pleura invasion.
3. Solid cements in the GGO less than 50%.
4. No other sites of disease observed.
5. Patient is not a candidate for surgical removal of the cancer, or refused surgery.
6. Patient is not a candidate for radiation therapy, or refused radiation therapy.
7. Patient has > 6 month life expectancy.
8. Eastern Cooperative Oncology Group performance status of 0 to 2.
9. No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
10. Sufficient organ functions.
11. Written informed consent.

Exclusion criteria

1. Active bacterial or fungous infection.
2. Simultaneous or metachronous (within the past 5 years) double cancers.
3. Women during pregnancy or breast-feeding.
4. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
5. Uncontrollable diabetes mellitus. History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Microwave ablation in the GGO

Experimental group

Description:

Patients with GGO were treated with microwave ablation.

Treatment:

Other: Microwave ablaton