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Microwave Ablation in Ground Glass Nodules

Microwave Ablation in Ground Glass Nodules

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03490890
Enrollment
200
Registered
2018-04-06
Start date
2018-05-01
Completion date
2025-04-30
Last updated
2018-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Microwave Ablation

Keywords

microwave ablation, lung cancer, ground glass nodules

Brief summary

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.

Detailed 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.

Interventions

OTHERMicrowave ablaton

Patients with pathology verified GGO were treated with MWA.

Sponsors

Shandong Provincial Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

All patient with GGO were treated with microwave ablation

Intervention model description

All patient with GGO were treated with microwave ablation

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The survival of patients with GGO treated with MWAFrom the date of randomization until the date of the date of death from any cause, assessed up to 60 monthsThe overall survival

Secondary

MeasureTime frameDescription
The disease free survival of patients with GGO treated with MWAFrom date of randomization until the date of first documented progression, assessed up to 60 monthsThe disease free survival

Other

MeasureTime frameDescription
Number of participants with treatment-related adverse events as assessed by CTCAE v4.01 yearThe safety

Countries

China

Contacts

Primary ContactXin Ye
yexintaian2014@163.com+86 0531-68773172
Backup ContactZhi g Wei
weizhigang321321@163.com+86 0531-68773171

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026