Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-29 @ 10:29 AM
Study NCT ID:
NCT05745961
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2023-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantifying 18kDa TSPO Expression in the Lung in Pulmonary Artery Hypertension (PAH)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C526315', 'term': '(methyl-(11)C)N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-14', 'studyFirstSubmitDate': '2023-02-16', 'studyFirstSubmitQcDate': '2023-02-16', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The specific and non-specific fractions of the [11C]PBR28 signal in the lungs of healthy individuals and PAH patients.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Arterial Hypertension', 'Healthy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine whether there is an increase in the TSPO PET signal (measured with the radioligand \\[11C\\]PBR28) in the lungs of patients living with PAH relative to age matched controls. If so, TSPO PET may be a useful technique to non-invasively monitor response to therapy. To do this, we will perform 2 \\[11C\\]PBR28 PET scans. The first will quantify the total \\[11C\\]PBR28 PET signal. This signal is a combination of the specific signal (VS) and the nonspecific signal (VND). The second scan will be performed following dosing with an unlabelled TSPO ligand. By directly measuring the total \\[11C\\]PBR28 signal (scan 1) and the nonspecific \\[11C\\]PBR28 signal (scan 2) we can therefore calculate the specific \\[11C\\]PBR28 signal, and hence the amount of TSPO in the lung.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'PAH patients and healthy volunteers', 'eligibilityCriteria': "Inclusion Criteria:\n\nAble to provide written informed consent prior to any study mandated procedures.\n\nAble to lie comfortably on back for up to 90 minutes at a time.\n\nFertile females (women of childbearing potential) are eligible to participate after a negative highly sensitive pregnancy test, if they are taking a highly effective method of contraception other than the oral contraceptive pill until the end of relevant systemic exposure.\n\nMale participants who are fertile are eligible to participate if they are willing to comply with the contraceptive requirements\n\nExclusion Criteria:\n\nUnable to provide informed consent and/or are non-fluent speakers of the English language\n\nTT Genotype at the rs6971 locus\n\nClinically-significant renal disease (confirmed by creatinine clearance \\<30 ml/min per 1.73m2)\n\nClinically-significant liver disease (confirmed by serum transaminases \\>2 times than upper normal limit)\n\nAnaemia confirmed by haemoglobin concentration \\<10 g/dl\n\nSickle cell disease or thalassaemia\n\nHistory of uncontrolled systemic hypertension\n\nAcute infection (including eye, dental, and skin infections)\n\nChronic inflammatory disease including HIV, and Hepatitis B\n\nWomen of childbearing potential who are pregnant or breastfeeding\n\nPatients who have received an Investigational Medicinal Product (IMP) within 5 half-lives of the last dose of the IMP or 1 month (which ever is greater) before the baseline visit\n\nParticipation in a research study involving significant ionisation radiation within the last 3 years\n\nSignificant radiation exposure other than dental X-rays in last 1 year\n\nPositive Allen's test.\n\n\\-"}, 'identificationModule': {'nctId': 'NCT05745961', 'briefTitle': 'Quantifying 18kDa TSPO Expression in the Lung in Pulmonary Artery Hypertension (PAH)', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Quantifying 18kDa TSPO Expression in the Lung in Pulmonary Artery Hypertension (PAH)', 'orgStudyIdInfo': {'id': '22HH8097'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PAH', 'interventionNames': ['Radiation: TSPO PET scan (11C-PBR28)']}, {'label': 'Healthy volunteer', 'interventionNames': ['Radiation: TSPO PET scan (11C-PBR28)']}], 'interventions': [{'name': 'TSPO PET scan (11C-PBR28)', 'type': 'RADIATION', 'description': 'PET scan', 'armGroupLabels': ['Healthy volunteer', 'PAH']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW3 2LE', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'David Owen, MD PhD', 'role': 'CONTACT', 'email': 'd.owen@imperial.ac.uk', 'phone': '07801140800'}], 'facility': 'Imperial Clinical Research Facility', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Martin Wilkins', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}