Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:43 PM
Study NCT ID:
NCT06907693
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-16
First Post:
2025-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Drug Candidate CS1 on Lung Structure and Function Utilizing FRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2025-03-27', 'studyFirstSubmitQcDate': '2025-03-27', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio of BV5A to BV10A', 'timeFrame': 'From baseline CT scan to 12 month CT scan', 'description': 'Change from baseline to month 12 in the ratio BV5A/BV10A'}], 'secondaryOutcomes': [{'measure': 'Ratio of BV5A to BV5APR', 'timeFrame': 'From baseline CT scan to 12 month CT scan', 'description': 'Change from baseline CT scan to 12 month CT scan regarding the ratio of the BV5A to BV5APR variable.'}, {'measure': 'Ratio of BV5A to BV5APRA', 'timeFrame': 'From baseline CT scan to 12 month CT scan', 'description': 'Change from baseline CT scan to 12 month CT scan regarding the ratio of the BV5A to BV5APRA variable.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FLUIDDA FRI', 'FRI'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '1. US EPA O. Frequent Questions: Radiation in Medicine. www.epa.gov. Published December 4, 2023. https://www.epa.gov/radiation/frequent-questions-radiation-medicine'}]}, 'descriptionModule': {'briefSummary': 'Explore the impact of drug candidate CS1 on pathological vascular remodeling of small pulmonary arteries in the disease pulmonary arterial hypertension (PAH). This sub-study for CS1-004 aims to utilize FRI, an innovative, non-invasive imaging technology to visualize how long-term use of CS1 influences structural changes in pulmonary arteries. This sub-study seeks to provide valuable insights into the potential of CS1 to transform PAH treatment in some patients enrolled in the Expanded Access Program (CS1-004).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participation in the CS1-004 clinical trial at Prisma Health-Upstate', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participation in the CS1-004 clinical trial\n\nExclusion Criteria:\n\n* Inability to undergo a CT pulmonary angiography scan (i.e., claustrophobia)\n* Individuals who are pregnant or who become pregnant during the sub-study\n* eGFR \\<30 mL/min/1.73m2 as calculated by Modification of Diet in Renal Disease (MDRD)\n* Allergy to Iodine contrast agents'}, 'identificationModule': {'nctId': 'NCT06907693', 'briefTitle': 'The Effects of Drug Candidate CS1 on Lung Structure and Function Utilizing FRI', 'organization': {'class': 'OTHER', 'fullName': 'Prisma Health-Upstate'}, 'officialTitle': 'The Effects of Drug Candidate CS1 on Lung Structure and Function Utilizing FRI, a Non-Invasive, Functional Respiratory Imaging System', 'orgStudyIdInfo': {'id': '2282898'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CT Pulmonary Angiography Recipient', 'description': 'All subjects in this study will undergo CT pulmonary angiography scans at baseline (+/- 2 months from start of drug therapy), 4 months and 12 months.', 'interventionNames': ['Diagnostic Test: CT Pulmonary Angiography Scan']}], 'interventions': [{'name': 'CT Pulmonary Angiography Scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'Computed tomography (CT) pulmonary angiography scan of the chest with IV contrast', 'armGroupLabels': ['CT Pulmonary Angiography Recipient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prisma Health-Upstate', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cereno Scientific AB', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}