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CT-guided Microwave Ablation in Ground Glass Nodules

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652350
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Wuxi People's Hospital

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.

Condition or disease Intervention/treatment Phase
Ground Glass Nodules Less Than 3cm Procedure: CT-guided microwave ablation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Exam the Flexibility, Safety and Efficacy of Using Microwave Ablation in Patients With Ground Glass Nodules
Actual Study Start Date : September 13, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Use CT-guided microwave ablation in Ground Glass Nodules ≤ 3cm
Patients with Ground Glass Nodules ≤ 3cm were treated with CT-guided microwave ablation
Procedure: CT-guided microwave ablation
Using thermal ablation electrode ECO-100AL6 probe target the GGN zone with the guidance performed by CT (Bright Speed Scanner )




Primary Outcome Measures :
  1. Number of participants recruited; Number of participants complied with protocol; Number of participants finished the study; Number of participants withdrew from the study [ Time Frame: 6 months ]
    Feasibility data that help identify potential population target of CT-guided microwave ablation


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events assessed by CTCAE v4.0 [ Time Frame: 6 months ]
    Safety data of CT-guided microwave ablation

  2. Number of participants successfully removed ground glass nodules and no relapse in follow-up visit [ Time Frame: 6 months ]
    Efficacy data of CT-guided microwave ablation

  3. Confounding variables identified that interfere with efficacy of microwave ablation [ Time Frame: 6 months ]
    Age, sex, medical history and ground glass nodules size examined by regression analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652350


Contacts
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Contact: Jian Bao, MD 13358119776 13358119776@189.cn
Contact: Peihua Lu, MD 13621500031 13621500031@189.cn

Locations
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China, Jiangsu
Wuxi People's Hospital Recruiting
Wuxi, Jiangsu, China, 214023
Contact: Jian Bao, MD    13358119776    13358119776@189.cn   
Contact: Peihua Lu, MD    13621500031    13621500031@189.cn   
Principal Investigator: Jian Bao, MD         
Principal Investigator: Peihua Lu, MD         
Sponsors and Collaborators
Wuxi People's Hospital

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Responsible Party: Wuxi People's Hospital
ClinicalTrials.gov Identifier: NCT03652350    
Other Study ID Numbers: KYLLH2018039
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors