Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 2:14 PM
Study NCT ID:
NCT01235494
Status:
COMPLETED
Last Update Posted:
2021-12-29
First Post:
2010-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of New MRI Pulse Sequences for Probing Lung Function in Volunteers With Hyperpolarised 3He Gas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-13', 'studyFirstSubmitDate': '2010-11-04', 'studyFirstSubmitQcDate': '2010-11-04', 'lastUpdatePostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'To develop techniques with MRI of Helium-3 gas to give functional images of the lungs. The goal is to test a single breath-hold functional 3-He MRI pulse sequence with sensitivity to multiple functional aspects of the luncg physiology. A group of 20 healthy volunteers willbe recruited from the local research group and the results compared with existing methods that require seperate breath-holds of 3He gas'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 -70\n\nExclusion Criteria:\n\n* contraindication to MRI\n* Resting oxygen saturation \\<95%\n* Volunteers requiring bronchodilators less than 4 hourly\n* additional respiratory diagnoses\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01235494', 'briefTitle': 'Development of New MRI Pulse Sequences for Probing Lung Function in Volunteers With Hyperpolarised 3He Gas', 'organization': {'class': 'OTHER', 'fullName': 'Sheffield Teaching Hospitals NHS Foundation Trust'}, 'officialTitle': 'Development of New MRI Pulse Sequences for Probing Lung Function in Volunteers With Hyperpolarised 3He Gas', 'orgStudyIdInfo': {'id': 'STH15080'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'polarised 3 helium', 'description': 'inhaled gas', 'interventionNames': ['Other: polarised 3 helium']}], 'interventions': [{'name': 'polarised 3 helium', 'type': 'OTHER', 'description': '1 inhalation (= 1 litre)', 'armGroupLabels': ['polarised 3 helium']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S10 2SJ', 'city': 'Sheffield', 'state': 'South Yorkshire', 'country': 'United Kingdom', 'facility': 'Academic Unit of Radiology, Univeristy of Sheffield', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Sheffield', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}