Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-02 @ 7:06 AM
Study NCT ID:
NCT05845151
Status:
UNKNOWN
Last Update Posted:
2023-05-06
First Post:
2023-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fibroblast Activating Protein Inhibitor PET Imaging in Lupus Nephritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-04', 'studyFirstSubmitDate': '2023-04-24', 'studyFirstSubmitQcDate': '2023-05-04', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal FAP expression level', 'timeFrame': 'Baseline', 'description': 'Quantitative assessment of renal fibroblast activation on FAPI PET image'}, {'measure': 'Renal FAP expression level', 'timeFrame': '6 months after baseline', 'description': 'Quantitative assessment of renal fibroblast activation on FAPI PET image'}, {'measure': 'Renal FAP expression level', 'timeFrame': '12 months after baseline', 'description': 'Quantitative assessment of renal fibroblast activation on FAPI PET image'}, {'measure': 'Renal FAP expression level', 'timeFrame': '24 months after baseline', 'description': 'Quantitative assessment of renal fibroblast activation on FAPI PET image'}], 'secondaryOutcomes': [{'measure': 'Renal fibrosis score', 'timeFrame': 'Baseline', 'description': "It's an immunohistochemical staining-based score after renal puncture. Higher score means a worse outcome."}, {'measure': 'Chronic activity score', 'timeFrame': 'Baseline', 'description': "It's an immunohistochemical staining-based scores after renal puncture. Higher score means a worse outcome."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lupus Nephritis']}, 'descriptionModule': {'briefSummary': 'Abnormal high expression of fibroblast activating protein (FAP) has been found in inflammatory reactions and benign fibrosis tissue. Autoimmune nephropathy such as lupus nephritis (LN) can lead to tubular atrophy and excessive deposition of extracellular matrix, which may be accompanied by abnormally increased expression of activated FAP in kidney tissue, and lead to renal fibrosis and long-term renal failure. This makes 68Ga-labeled FAP inhibitor (FAPI) positron emission tomography (PET) imaging the potential to early assess disease severity, predict disease progress and aid treatment planning in patients with LN. Compared to renal pathological puncture, 68Ga-FAPI PET is a new tool for non-invasive, repeatable assessment of renal fibrotic activation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be between 18-80 years old;\n* Confirmed SLE: meet the 2019 EULAR/ACR classification standards;\n* There are signs of renal involvement and indications for renal puncture: proteinuria\\> 0.5g/24 hours (or urine protein creatine ratio (UPCR) \\>500mg/g), unexplained decrease of glomerular filtration rate (GFR)\n\nExclusion Criteria:\n\n* The pathology of renal puncture is not consistent with lupus nephritis;\n* Previous history of other kidney diseases;\n* There are contraindications to renal puncture: (1) obvious bleeding tendency, (2) severe hypertension, (3) psychosis or non-cooperative patients, (4) isolated kidney, (5) small kidney;\n* History of malignant tumors within 5 years.'}, 'identificationModule': {'nctId': 'NCT05845151', 'briefTitle': 'Fibroblast Activating Protein Inhibitor PET Imaging in Lupus Nephritis', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Fibroblast Activating Protein Inhibitor PET Imaging for Molecular Assessment of Fibroblast Activation and Risk Evaluation in Patients With Lupus Nephritis', 'orgStudyIdInfo': {'id': '(2021)CER(87)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LN Patients group', 'interventionNames': ['Diagnostic Test: 68Ga-FAPI-04 PET']}], 'interventions': [{'name': '68Ga-FAPI-04 PET', 'type': 'DIAGNOSTIC_TEST', 'description': 'Activation of renal fibroblast is quantified using 68Ga-FAPI-04 PET in patients with LN.', 'armGroupLabels': ['LN Patients group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Zhang, Dr.', 'role': 'CONTACT', 'email': 'zm11518@rjh.com.cn', 'phone': '0086-21-64370045'}], 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hui Shi, Dr.', 'role': 'CONTACT', 'email': 'shihui_sjtu@sina.com', 'phone': '0086 21 64370045'}], 'overallOfficials': [{'name': 'Hui Shi, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}