Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-23 @ 12:20 PM
Study NCT ID:
NCT02616757
Status:
WITHDRAWN
Last Update Posted:
2021-04-21
First Post:
2015-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001845', 'term': 'Bone Cysts'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Ultrasound machine was no longer approved for use by Health Canada therefore study was closed prior to patients being enrolled on study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-20', 'studyFirstSubmitDate': '2015-11-25', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Z-scores obtained using quantitative ultrasound', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Bone specific alkaline phosphatase', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Simple Bone Cyst']}, 'descriptionModule': {'briefSummary': 'Simple bone cysts (SBCs), also known as unicameral bone cysts (UBCs), are benign bone lesions. Literature to date describes little agreement between clinicians on specific prognostic criteria for the prediction of cyst healing, recurrence or fracture. Evidence has shown that bone mineral density (BMD) is a reliable indicator of risk to SBC patients given its association with the mechanical properties of bone. There has been further exploration into the use of quantitative ultrasound to assess bone density by measuring the velocity of the ultrasound transmission over the bone. To determine whether the QUS can provide prognostic information with respect to cyst healing, recurrence or fracture with a SBC, further study is needed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Arm 1 - Simple Bone Cyst Patients\n\nInclusion Criteria\n\n1. Patients ≥ 2 and ≤ 21 years\n2. Patients with a diagnosis of simple bone cyst located in a long bone confirmed by imaging within 3 months prior to registration\n3. All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.\n\nExclusion Criteria\n\n1. Patients with implants to stabilize the bone where the cyst is located.\n2. Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)\n3. Patients who are pregnant or breastfeeding\n4. Patients with a simple bone cyst crossing the growth plate\n\nArm 2 - Healthy Controls\n\nInclusion Criteria\n\n1. Patients ≥ 2 and ≤ 21 years\n2. All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.\n\nExclusion Criteria\n\n1. Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)\n2. Patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.)\n3. Patients who are pregnant or breastfeeding\n\nArm 3 - Fracture patients\n\nInclusion Criteria\n\n1. Patients ≥ 2 and ≤ 21 years\n2. Patients who have undergone any type of casting or surgical treatment for their fracture\n3. All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.\n\nExclusion Criteria\n\n1. Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)\n2. Patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.)\n3. Patients who are pregnant or breastfeeding"}, 'identificationModule': {'nctId': 'NCT02616757', 'briefTitle': 'Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing', 'orgStudyIdInfo': {'id': '1000049774'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Simple Bone Cyst Patients', 'description': 'Z-score measurements will be taken from the mid-shaft tibia and distal third of the radius of both extremities where possible using quantitative ultrasound at baseline and once annually for 2 years.\n\nThere will also be optional blood samples taken o measure bone alkaline phosphatase.', 'interventionNames': ['Device: Sunlight Omnisense Quantitative Ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fracture patients', 'description': 'Z-score measurements will be taken from the mid-shaft tibia and distal third of the radius of both extremities where possible using quantitative ultrasound at baseline, after 3 months and at future follow-up visits as clinically indicated or at a one year follow-up visit.\n\nThere will also be optional blood samples taken to measure bone alkaline phosphatase.', 'interventionNames': ['Device: Sunlight Omnisense Quantitative Ultrasound']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Health volunteers', 'description': 'Z-score measurements will be taken from the mid-shaft tibia and distal third of the radius of both extremities where possible using quantitative ultrasound at baseline, after 3 months and at a one year follow-up visit.\n\nThere will also be optional blood samples taken to measure bone alkaline phosphatase.', 'interventionNames': ['Device: Sunlight Omnisense Quantitative Ultrasound']}], 'interventions': [{'name': 'Sunlight Omnisense Quantitative Ultrasound', 'type': 'DEVICE', 'description': 'Ultrasound', 'armGroupLabels': ['Fracture patients', 'Health volunteers', 'Simple Bone Cyst Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Andrew Howard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}, {'name': 'James G. Wright, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nuffield Orthopaedic Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopaedic Surgeon', 'investigatorFullName': 'James Wright', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}