Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-03-31 @ 8:02 PM
Study NCT ID:
NCT02488304
Status:
TERMINATED
Last Update Posted:
2018-03-21
First Post:
2015-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'the lung transplantation program at the site is on hold', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-19', 'studyFirstSubmitDate': '2015-06-26', 'studyFirstSubmitQcDate': '2015-06-30', 'lastUpdatePostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Airway Volume (iVaw) using FRI', 'timeFrame': '3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant', 'description': 'Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.'}, {'measure': 'Change in Airway Resistance (iRaw) using FRI', 'timeFrame': '3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant', 'description': 'Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. Airway resistance is defined as the pressure drop over the airways divided by the airflow.'}, {'measure': 'Change in Specific Airway Volume (siVaw) using FRI', 'timeFrame': '3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant', 'description': 'Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.'}, {'measure': 'Change in Specific Airway Resistance (siRaw) using FRI', 'timeFrame': '3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant', 'description': 'Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.'}, {'measure': 'Change in Lobe Volumes (iVlobes) using FRI', 'timeFrame': '3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant', 'description': 'Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.'}, {'measure': 'Change in Air trapping using FRI', 'timeFrame': '3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant', 'description': 'Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. Air trapping is defined as the regions in the lung with a gray value on the CT-scan image smaller than -850 HU at functional residual capacity.'}, {'measure': 'Change in Internal Lobar Airflow Distribution using FRI', 'timeFrame': '3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant', 'description': 'Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. Airflow distribution is defined in as the percentage of air going to every lobe when inhaling from FRC to TLC and is calculated for every lobe as: IALDlobe \\[%\\] = 100 (VTLC\\_lobe - VFRC\\_lobe) / (VTLC\\_lungs - VFRC\\_lungs).'}, {'measure': 'Change in Low Attenuation or Emphysema Score using FRI', 'timeFrame': '3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant', 'description': 'Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.'}, {'measure': 'Change in Blood Vessel Density or Fibrosis Score using FRI', 'timeFrame': '3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant', 'description': 'Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.'}, {'measure': 'Change in Airway Wall Thickness using FRI', 'timeFrame': '3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant', 'description': 'Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HRCT', 'High Resolution Computed Tomography scans', 'Functional Respiratory Imaging', 'FRI', 'Computed Tomography', 'CT', 'Bronchiolitis Obliterans Syndrome', 'BOS', 'Lung Transplant'], 'conditions': ['Bronchiolitis Obliterans', 'Lung Transplant Rejection']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to detect BOS in an early stage by using the outcome parameters generated by Functional Respiratory Imaging (FRI). Robust and automated segmentation algorithms will be developed for these parameters, focusing on quantitative computed tomography (CT) image analyses to provide the physician a more sensitive diagnostics tool. The evolution of rejection over time will be monitored using non-rigid image registration methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patient ≥ 18 years old\n* Written informed consent obtained\n* Patients who are planned to receive a lung transplant in the near future\n* Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before screening visit and will continue to use a contraception method during the study\n* The patient must be able to perform the lung monitoring at home\n\nExclusion Criteria:\n\n* Pregnant or lactating female\n* Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation'}, 'identificationModule': {'nctId': 'NCT02488304', 'briefTitle': 'Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'FLUIDDA nv'}, 'officialTitle': 'Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)', 'orgStudyIdInfo': {'id': 'FLUI-2015-141'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HRCT scans', 'description': 'High Resolution Computed Tomography scans will be taken', 'interventionNames': ['Radiation: HRCT scans']}], 'interventions': [{'name': 'HRCT scans', 'type': 'RADIATION', 'otherNames': ['High Resolution Computed Tomography scans'], 'description': 'A HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 2, visit 3, visit 4, visit 5, visit 6, and visit 7.\n\nAn upper airway (UA) scan will be taken on visit 2.', 'armGroupLabels': ['HRCT scans']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'Antwerp University Hospital', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}], 'overallOfficials': [{'name': 'Wilfried De Backer, M.D., M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Antwerp'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FLUIDDA nv', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}