Microwave Ablation in Ground Glass Nodules

NCT ID: NCT03490890

Last Updated: 2018-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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Microwave Ablation Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All patient with GGO were treated with microwave ablation
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

All patient with GGO were treated with microwave ablation

Study Groups

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Microwave ablation in the GGO

Patients with GGO were treated with microwave ablation.

Group Type EXPERIMENTAL

Microwave ablaton

Intervention Type OTHER

Patients with pathology verified GGO were treated with MWA.

Interventions

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Microwave ablaton

Patients with pathology verified GGO were treated with MWA.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Provincial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Xin Ye

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xin Ye

Role: STUDY_DIRECTOR

Shandong Provincial Hospital

Locations

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Binzhou Medical University Hospital

Binzhou, Shandong, China

Site Status

Dezhou People's Hospital

Dezhou, Shandong, China

Site Status

The Second People's Hospital of Dezhou

Dezhou, Shandong, China

Site Status

Jinan Military General Hospital

Jinan, Shandong, China

Site Status

Affliated Hospital of Shandong Academy of Medical Sciences

Jinan, Shandong, China

Site Status

Shandong Provincial Hospital

Jinan, Shandong, China

Site Status

Shandong Provincial Hospital affliated to Shandong University

Jinan, Shandong, China

Site Status

Affliated Hospital of Jining Medical University

Jining, Shandong, China

Site Status

Liaocheng Cancer Hospital

Liaocheng, Shandong, China

Site Status

The People's Hospital of Pingyi Country

Linyi, Shandong, China

Site Status

Affliated Hospital of Taishan Medical University

Taian, Shandong, China

Site Status

The People's Liberation Army 88 Hospital

Taian, Shandong, China

Site Status

Weifang People's Hospital

Weifang, Shandong, China

Site Status

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Site Status

Tengzhou center of people's hospital

Zaozhuang, Shandong, China

Site Status

Countries

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China

Central Contacts

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Xin Ye

Role: CONTACT

+86 0531-68773172

Zhi g Wei

Role: CONTACT

+86 0531-68773171

Other Identifiers

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Shandong PH JN

Identifier Type: -

Identifier Source: org_study_id

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