Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-29 @ 2:48 AM
Study NCT ID:
NCT07045532
Status:
RECRUITING
Last Update Posted:
2025-07-01
First Post:
2025-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment the Effectiveness of BTVA in COPD and Ablation in Pulmonary Nodules by Pulmonary MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-22', 'studyFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2025-06-22', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PREFUL-MRI Ventilation and Perfusion Parameters in Patients with COPD Following Lung Volume Reduction Surgery with Thermal Steam', 'timeFrame': 'From enrollment to 6 months post-surgery', 'description': "Using the Phase-Resolved Functional Lung(PREFUL)-MRI dedicated post-processing analysis software, we can obtain images of the patient's lung ventilation and perfusion status."}, {'measure': 'PREFUL-MRI Ventilation and Perfusion Parameters in Patients with COPD Following Lung Volume Reduction Surgery with Thermal Steam', 'timeFrame': 'From enrollment to 6 months post-surgery', 'description': 'Percentage of perfusion defect (QDP)：Calculation of QDP based on PREFUL-MRI dedicated post-processing software'}, {'measure': 'PREFUL-MRI Ventilation and Perfusion Parameters in Patients with COPD Following Lung Volume Reduction Surgery with Thermal Steam', 'timeFrame': 'From enrollment to 6 months post-surgery', 'description': 'Percentage of ventilation defect (VDP)：Calculation of VDP based on PREFUL-MRI dedicated post-processing software'}, {'measure': 'PREFUL-MRI Ventilation and Perfusion Parameters in Patients with COPD Following Lung Volume Reduction Surgery with Thermal Steam', 'timeFrame': 'From enrollment to 6 months post-surgery', 'description': 'Percentage of ventilation-perfusion match (VQM):Calculation of VQM based on PREFUL-MRI dedicated post-processing software'}, {'measure': 'Quantitative Hemodynamic Analysis Parameters Based on Tofts Model Using GRASP-MRI After Ablation of Solid Pulmonary Nodules', 'timeFrame': 'From enrollment to 3 months post-surgery', 'description': 'Quantitative parameters of GRASP-MRI images based on the Tofts model:\n\nVolume transfer coefficient(Ktrans)(/min)：the rate transfer constant of gadolinium between plasma and tissue interstitium;'}, {'measure': 'Quantitative Hemodynamic Analysis Parameters Based on Tofts Model Using GRASP-MRI After Ablation of Solid Pulmonary Nodules', 'timeFrame': 'From enrollment to 3 months post-surgery', 'description': 'Quantitative parameters of GRASP-MRI images based on the Tofts model:\n\nInterstitial volume(Ve)(0～1)：the extracellular-extravascular volume;'}, {'measure': 'Quantitative Hemodynamic Analysis Parameters Based on Tofts Model Using GRASP-MRI After Ablation of Solid Pulmonary Nodules', 'timeFrame': 'From enrollment to 3 months post-surgery', 'description': 'Quantitative parameters of GRASP-MRI images based on the Tofts model:\n\nKep: Backflow rate constant, reflecting the time constant for returning from EES to the vascular system, Kep = Ktrans / Ve.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI', 'COPD', 'Lung cancer', 'ablation'], 'conditions': ['COPD', 'Lung Cancers']}, 'descriptionModule': {'briefSummary': 'A Clinical Study Based on Magnetic Resonance Imaging of the Lungs to Assess the Efficacy of Thermal Vapor Ablation and Pulmonary Nodule Ablation in Chronic Obstructive Pulmonary Disease After Surgery.\n\nThe efficacy of hot steam ablation for chronic obstructive pulmonary disease was evaluated using the innovative MRI sequence PREFUL\\_MRI, and the efficacy of pulmonary nodule ablation was evaluated using the innovative MRI sequence GRASP\\_MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients older than 18 years of age with pulmonary nodules and COPD.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>18 years old;\n2. Patients with pulmonary nodules: patients with pulmonary nodules indicated by chest CT, pathologically diagnosed as malignant, and receiving ablative treatment, including transthoracic and percutaneous ablative methods, including radiofrequency, microwave, and freezing;\n3. COPD patients: patients diagnosed with COPD according to the GOLD principle and treated with thermal steam ablation for COPD;\n4. Understand the study and sign the informed consent.\n\nExclusion Criteria:\n\n1. Chest CT nodules in patients with pulmonary nodules were pure ground glass nodules;\n2. Patients who install or carry metal implants such as cardiac pacemakers, heart stents, artificial heart valves in the body or suffer from claustrophobia, allergy to contrast media and other reasons are not suitable for MRI examination;\n3. severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of ablation surgery;\n4. Patients with severe COPD exacerbation or pneumonia in the past four weeks;'}, 'identificationModule': {'nctId': 'NCT07045532', 'briefTitle': 'Assessment the Effectiveness of BTVA in COPD and Ablation in Pulmonary Nodules by Pulmonary MRI', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'Assessment the Effectiveness of Bronchoscopic Thermal Vapor Ablation in Chronic Obstructive Pulmonary Disease and Ablation in Pulmonary Nodules by Pulmonary Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': 'KS(Y)23216'}}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Ye, MD', 'role': 'CONTACT', 'email': 'sjtuyl@163.com', 'phone': '021-62821990'}, {'name': 'Jiayuan Sun, MD, PhD', 'role': 'CONTACT', 'email': 'xkyyjysun@163.com', 'phone': '021-62821990'}], 'facility': 'Shanghai chest hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Lin Ye, MD', 'role': 'CONTACT', 'email': 'sjtuyl@163.com', 'phone': '021-62821990'}, {'name': 'Jiayuan Sun, MD, PhD', 'role': 'CONTACT', 'email': 'xkyyjysun@163.com', 'phone': '021-62821990'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice dean of the hospital', 'investigatorFullName': 'Jiayuan Sun', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}