Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-01 @ 9:25 PM
Study NCT ID:
NCT04391335
Status:
RECRUITING
Last Update Posted:
2025-07-23
First Post:
2020-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'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': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2020-05-12', 'studyFirstSubmitQcDate': '2020-05-12', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of MRI', 'timeFrame': '24 months', 'description': 'Perform xenon MRI, in participants with and without a diagnosis of BOS as defined by NIH criteria.'}], 'secondaryOutcomes': [{'measure': 'Correlation', 'timeFrame': '24 months', 'description': 'Correlate MRI with conventional breathing tests'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stem cell transplantation', 'Xenon MRI', 'Lung'], 'conditions': ['Bronchiolitis Obliterans Syndrome']}, 'descriptionModule': {'briefSummary': 'In this study, we will study 129Xe-MRI and LCI as tools for diagnosis of BOS in pediatric patients who have received Hematopoietic Stem Cell Transplantation (HSCT) and have been identified as eligible for this study. Participants will be required to have vital signs collected, complete breathing tests and complete an MRI. The MRI will require participants to perform breath holds in the MRI scanner with xenon gas while being coached by a research assistant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Two groups of participants will be recruited. Group 1 will be participants who meet the screening criteria for the development of BOS according to the NIH criteria. Group 2 will be participants who may or may not have abnormal spirometry; however they do not fulfill the NIH criteria for the development of BOS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female participants aged 6 -17.9 years old.\n* Received HSCT treatment at least 6 months prior to enrollment in study.\n* Participants should have an FEV1%pred value greater than 40%.\n* Participant understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent or assent.\n* Participant must be able to perform a breath hold for 16s.\n* Participant meets MRI screening criteria\n\nExclusion Criteria:\n\n* Participant has had a cold or respiratory infection in the last four weeks.\n* Participant requires supplemental oxygen or has a daytime room air oxygen saturation ≤ 95%.\n* Participant is unable to perform spirometry or plethysmography maneuvers.\n* Participant is pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT04391335', 'briefTitle': 'Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children', 'orgStudyIdInfo': {'id': '1000063459'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Participants who meet the screening criteria for the development of bronchiolitis obliterans syndrome (BOS) according to the NIH criteria'}, {'label': 'Group 2', 'description': 'Participants who may or may not have abnormal spirometry; however they do not fulfill the NIH criteria for the development of BOS'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Giles Santyr, PhD FCCPM', 'role': 'CONTACT', 'email': 'giles.santyr@sickkids.ca'}, {'name': 'Sharon Braganza', 'role': 'CONTACT', 'email': 'sharon.braganza@sickkids.ca', 'phone': '416 813 7654', 'phoneExt': '307937'}, {'name': 'Giles Santyr, PhD FCCPM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Giles Santyr', 'role': 'CONTACT', 'email': 'giles.santyr@sickkids.ca', 'phone': '4168137654', 'phoneExt': '301394'}, {'name': 'Sharon Braganza', 'role': 'CONTACT', 'email': 'sharon.braganza@sickkids.ca', 'phone': '4168137654', 'phoneExt': '307937'}], 'overallOfficials': [{'name': 'Giles Santyr, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Scientist', 'investigatorFullName': 'Giles Santyr', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}