Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
Study NCT ID:
NCT07212959
Status:
COMPLETED
Last Update Posted:
2025-10-08
First Post:
2025-10-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
As Part of a Pilot Study, Visualization of Inflammatory Activity in Systemic Sclerosis Using CXCR4 PET/CT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-09', 'size': 457261, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-01T09:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2025-10-02', 'studyFirstSubmitQcDate': '2025-10-02', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Traceracktivity in CXCR4-PET/CT', 'timeFrame': '2 year', 'description': 'Measurement of the maximum measurable CXCR4 tracer activity in CXCR4 PET/CT in fibrotic pulmonal changes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SSc', 'CXCR4', 'PET/CT'], 'conditions': ['Systemic Sclerosis (SSc)']}, 'descriptionModule': {'briefSummary': 'Systemic sclerosis (SSc) is a heterogeneous clinical picture consisting of inflammatory, vasculopathic, and fibrotic changes.\n\nInitially, inflammatory changes usually occur, which result in fibrosis over time.\n\nThis affects various organ systems such as the lungs, skin, heart, and gastrointestinal tract. Early detection of inflammatory activity is therefore important in order to prevent consequential damage, in particular irreversible fibrosis. Since the inflammatory foci can spread throughout the entire body, there is a need to be able to detect inflammatory activity over a large area. The 68Ga-Pentiafor-based imaging of the CXCR4 chemokine receptor, which is expressed on immune system cells such as lymphocytes and macrophages, among others, offers a useful approach here, as it allows specific inflammatory cells that migrate to inflammatory lesions via the corresponding ligand (CXCL12) and are involved in the pathogenesis of SSc. To date, only chest CT has been used to diagnose and monitor the progression of pulmonary fibrosis in SSc. This non-functional imaging makes it virtually impossible to draw conclusions about inflammatory activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed diagnosis of SSc based on the 2013 ACR/EULAR criteria\n* Duration of disease less than 5 years (onset of the first non-Raynaud's symptom within the last 5 years)\n* Evidence of ILD on computed tomography\n* Patient's ability to understand the information provided\n* Patient of legal age\n\nExclusion Criteria:\n\n* Following autologous stem cell transplantation\n* Presence of pulmonary hypertension\n* Contraindications for performing a PET/CT scan - Pregnancy\n* Breastfeeding\n* Allergies to 68Ga-Pentixafor\n* Patient's inability to understand and give informed consent"}, 'identificationModule': {'nctId': 'NCT07212959', 'briefTitle': 'As Part of a Pilot Study, Visualization of Inflammatory Activity in Systemic Sclerosis Using CXCR4 PET/CT', 'organization': {'class': 'OTHER', 'fullName': 'Wuerzburg University Hospital'}, 'officialTitle': 'CXCR4-PET/CT for the Detection of Inflammatory Activity in Systemic Sclerosis', 'orgStudyIdInfo': {'id': '296/21-me'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CXCR4-PET/CT for detection von inflammatory changes in systemic sclerosis', 'interventionNames': ['Other: CXCR4-PET/CT']}], 'interventions': [{'name': 'CXCR4-PET/CT', 'type': 'OTHER', 'description': 'CXCR4-PET/CT for the detection of inflammatory activity in patient with active systemic sclerosis', 'armGroupLabels': ['CXCR4-PET/CT for detection von inflammatory changes in systemic sclerosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97078', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'University Hospital Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'MIcheal Armin Gernert, Privatdozent', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wuerzburg University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}