Microwave AblationPhase 2NCT03490890
Microwave Ablation in Ground Glass Nodules
A Phase 2 study testing Microwave ablaton in people with Microwave Ablation and Lung Cancer, run by Shandong Provincial Hospital at 15 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microwave Ablation, Lung Cancer
- What is being tested?
- Microwave ablaton
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 15 sitesChina
- Study dates
- 1 May 2018to 30 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has a histologically verified AIS or MIA.
- The tumors small enough to treat (usually ≤3 cm), and without chest pleura invasion.
- Solid cements in the GGO less than 50%.
- No other sites of disease observed.
- Patient is not a candidate for surgical removal of the cancer, or refused surgery.
- Patient is not a candidate for radiation therapy, or refused radiation therapy.
Show all 11Show fewer
- Patient has > 6 month life expectancy.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
- Sufficient organ functions.
- Written informed consent.
Who cannot join
- Active bacterial or fungous infection.
- Simultaneous or metachronous (within the past 5 years) double cancers.
- Women during pregnancy or breast-feeding.
- Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
- 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 locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Binzhou Medical University Hospital
Binzhou, Shandong, +86 256600
Dezhou People's Hospital
Dezhou, Shandong, +86 253000
The Second People's Hospital of Dezhou
Dezhou, Shandong, +86 253000
Jinan Military General Hospital
Jinan, Shandong, +83 250001
Affliated Hospital of Shandong Academy of Medical Sciences
Jinan, Shandong, +86 250001
Shandong Provincial Hospital
Jinan, Shandong, +86 250001
Shandong Provincial Hospital affliated to Shandong University
Jinan, Shandong, +86053168773172
Affliated Hospital of Jining Medical University
Jining, Shandong, +86 272000
Liaocheng Cancer Hospital
Liaocheng, Shandong, +86 252000
The People's Hospital of Pingyi Country
Linyi, Shandong, +86 276000
Affliated Hospital of Taishan Medical University
Taian, Shandong, +86 271000
The People's Liberation Army 88 Hospital
Taian, Shandong, +86 271000
Weifang People's Hospital
Weifang, Shandong, +86 262000
Yantai Yuhuangding Hospital
Yantai, Shandong, +86 264000
Tengzhou center of people's hospital
Zaozhuang, Shandong, +86 277000
About this study
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.
Read the 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.
- Conditions
- Microwave Ablation, Lung Cancer
- Being tested
- Microwave ablaton
- Keywords
- microwave ablation, lung cancer, ground glass nodules
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave ablatonOther
Patients with pathology verified GGO were treated with MWA.
| Study group | Role | What they receive |
|---|---|---|
| Microwave ablation in the GGO | Experimental | Patients with GGO were treated with microwave ablation. Receives: Other: Microwave ablaton |
What is being measured
The primary outcome is the main question the study is designed to answer.
The survival of patients with GGO treated with MWA
The overall survival
Measured: From the date of randomization until the date of the date of death from any cause, assessed up to 60 months
Secondary outcomes (1)
The disease free survival of patients with GGO treated with MWA
The disease free survival
Measured: From date of randomization until the date of first documented progression, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start1 May 2018 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microwave AblationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patient with GGO were treated with microwave ablation
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xin Ye, Shandong Provincial Hospital
- Investigators
- Xin Ye, Study director, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490890
- Sponsor's protocol ID
- Shandong PH JN
- Status last verified
- Apr 2018
- First submitted
- 26 Mar 2018
- Last updated
- 9 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microwave Ablation in Ground Glass Nodules
- ClinicalTrials.gov ID
- NCT03490890
- Acronym / sponsor ID
- Shandong PH JN
- Conditions
- Microwave Ablation, Lung Cancer
- Keywords
- microwave ablation, lung cancer, ground glass nodules
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patient with GGO were treated with microwave ablation
| Arm | Type | Receives |
|---|---|---|
| Microwave ablation in the GGO | Experimental | Other: Microwave ablatonPatients with GGO were treated with microwave ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient has a histologically verified AIS or MIA.
- The tumors small enough to treat (usually ≤3 cm), and without chest pleura invasion.
- Solid cements in the GGO less than 50%.
- No other sites of disease observed.
- Patient is not a candidate for surgical removal of the cancer, or refused surgery.
Key exclusion criteria (5 listed)
- Active bacterial or fungous infection.
- Simultaneous or metachronous (within the past 5 years) double cancers.
- Women during pregnancy or breast-feeding.
- Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave ablatonPatients with pathology verified GGO were treated with MWA. | Other | Microwave ablation in the GGO |
Primary outcome
The survival of patients with GGO treated with MWA
Time frame: From the date of randomization until the date of the date of death from any cause, assessed up to 60 months
The overall survival
1 secondary outcome
The disease free survival of patients with GGO treated with MWA
Time frame: From date of randomization until the date of first documented progression, assessed up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Microwave Ablation
Active, not recruitingObservational study
Pain During Heat Treatment for Lower Extremity Varicose Veins: Radiofrequency vs. Microwave
Lower Extremity Varicose Veins, Radiofrequency Ablation
Recruiting
Ultrasound-guided Microwave Ablation of Benign Thyroid Nodules
Thyroid Nodule (Diagnosis)
Not yet recruitingObservational study
A Retrospective Registry of Intelliblate DUAL Channel Microwave Ablation
Liver Ablation, Liver Cancer
Not yet recruiting
Management of Breast Fibroadenoma: Comparing Observation, Microwave Ablation, and Surgical Excision
Fibroadenoma, Breast Fibroadenoma
RecruitingObservational study
Variability of Microwave Ablation Volume Based on Clinical, Radiological, Biological, and Tissue Factors
Liver Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin Ye study director
Shandong Provincial Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Microwave ablaton in people with Microwave Ablation and Lung Cancer, run by Shandong Provincial Hospital at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Ye (+86 0531-68773172, yexintaian2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The survival of patients with GGO treated with MWA (time frame: From the date of randomization until the date of the date of death from any cause, assessed up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018.