Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-02-13 @ 9:47 AM
Study NCT ID:
NCT02377934
Status:
COMPLETED
Last Update Posted:
2022-11-04
First Post:
2015-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-03', 'studyFirstSubmitDate': '2015-02-27', 'studyFirstSubmitQcDate': '2015-02-27', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in pulmonary artery pressure', 'timeFrame': '6 and 12 weeks after completion chemoradiotherapy'}], 'secondaryOutcomes': [{'measure': 'Pulmonary artery velocity; right ventricle (RV) dimensions and RV-function', 'timeFrame': '6 and 12 weeks after completion chemoradiotherapy'}, {'measure': 'The assessment of RV-dimensions and RV-function', 'timeFrame': '6 and 12 weeks after completion chemoradiotherapy'}, {'measure': 'The incidence of clinical signs of radiation pneumonitis according to SWOG-criteria', 'timeFrame': '6 weeks after completion treatment'}, {'measure': 'The incidence of radiological signs of pulmonary fibrosis according to CTCAE4.0', 'timeFrame': '12 weeks after completion of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary Hypertension', 'Cardiac MRT', 'Radiotherapy'], 'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'In the radiotherapeutic treatment of lung cancer, the dose that can be safely applied to the tumour is limited by the risk of radiation induced lung damage. This damage is characterized by parenchymal damage and vascular damage. In rats, we have found that radiation-induced vascular damage results in increased pulmonary artery pressure. Interestingly, the consequent loss of pulmonary function could be fully explained by this increase in pulmonary artery pressure. We hypothesize that also in patients a radiation induced increase in pulmonary artery pressure can be observed after radiotherapy, which may contribute to the development of radiation pneumonitis.\n\nThe objective is to test the hypothesis that radiotherapy for lung cancer induces an increase in pulmonary artery pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with stage III NSCLC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* WHO PS 0-2\n* Histological or cytological confirmation of non-small cell lung cancer or an 18F-FDG-positive, growing mass on CT-thorax suggestive of NSCLC.\n* Stage IIIA or IIIB\n* Patients with extensive mediastinal lymph node involvement (such as N3), or large primary tumour size\n* Adequate pulmonary function estimated by flow volume curves\n* Life expectancy of at least 6 months\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol; those conditions should be discussed with the patient before registration in the trial.\n* Planned for 25 x 2.4 Gy, with concomitant chemotherapy\n* Before patient registration, written informed consent will be obtained.\n\nExclusion Criteria:\n\n* Presence of contra-indications for undergoing MRI'}, 'identificationModule': {'nctId': 'NCT02377934', 'acronym': 'MRI-HART', 'briefTitle': 'Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study', 'orgStudyIdInfo': {'id': 'RT2011-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cardiac Magnetic Resonance Imaging (MRI)', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9700RB', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Robin Wijsman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}