Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-02-24 @ 12:26 AM
Study NCT ID:
NCT05506566
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2022-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707753', 'term': '68Ga-FAPI'}, {'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}], 'ancestors': [{'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-16', 'studyFirstSubmitDate': '2022-08-14', 'studyFirstSubmitQcDate': '2022-08-17', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Human biodistribution', 'timeFrame': 'From right after tracer injection to 2-hours post-injection', 'description': 'reported as relative uptake values per organ at 30s, 15min, 30min, 60min and 120 min per individual subject and as a mean over all subjects (Part I)'}, {'measure': 'Human dosimetry', 'timeFrame': 'From right after tracer injection to 2-hours post-injection', 'description': 'radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects (Part I). Dosimetry will be calculated using the OLINDA software.'}, {'measure': 'Standard uptake value (SUV)', 'timeFrame': 'Up to 2 weeks', 'description': 'Determination of SUV for detected lesions and discernible organs of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG'}, {'measure': 'Lesion numbers', 'timeFrame': 'Up to 2weeks', 'description': 'Determination of lesion numbers of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG'}, {'measure': 'the sensitivity of 68Ga-FAP-CHX PET/CT', 'timeFrame': 'Up to 2 weeks', 'description': 'compared with pathology or composite imaging, the sensitivity of 68Ga-FAP-CHX PET/CT was evaluated.'}, {'measure': 'the specificity of 68Ga-FAP-CHX PET/CT', 'timeFrame': 'Up to 2 weeks', 'description': 'compared with pathology or composite imaging, the specificity of 68Ga-FAP-CHX PET/CT was evaluated.'}, {'measure': 'the accuracy of 68Ga-FAP-CHX PET/CT', 'timeFrame': 'Up to 2 weeks', 'description': 'compared with pathology or composite imaging, the accuracy of 68Ga-FAP-CHX PET/CT was evaluated.'}], 'secondaryOutcomes': [{'measure': 'Count of participants with treatment emergent adverse events', 'timeFrame': 'Up to 3 days', 'description': 'The frequency and severity of treatment emergent adverse events following 68Ga-FAP-CHX injection will be descriptively reported as classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0'}, {'measure': 'Expression ability of 68Ga-FAP-CHX in different types of tumors', 'timeFrame': 'Up to 3 days', 'description': 'Differentiation of SUVmax in different tumors'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tumor', 'Positron-Emission Tomography']}, 'descriptionModule': {'briefSummary': 'As an emerging molecule targeting FAP, 68Ga-FAP-CHX is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAP-CHX in patients with various types of cancer and compared them with the results of 68Ga-FAPI-04 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-CHX.', 'detailedDescription': 'Fibroblast activation protein (FAP) is highly expressed in the stroma of a variety of human cancers and is therefore considered promising for guiding targeted therapy. The recent development of quinoline-based PET tracers that act as FAP inhibitors (FAPIs) demonstrated promising results preclinically and already in a few clinical cases. 68Ga-FAP-CHX is a novel FAP-targeted tracers. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-FAP-CHX, and performed a head-to-head comparison with 68Ga-FAPI-04 or 18F-FDG PET/CT scans in patients with various cancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years \\< Age \\< 75 years\n* Various solid tumors with available histopathological findings, and have not been treated surgically.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* patients with pregnancy\n* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT05506566', 'briefTitle': '68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Fujian Medical University'}, 'officialTitle': '68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies', 'orgStudyIdInfo': {'id': 'FirstAHFujian-FAP-CHX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part I: safety, tolerability, biodistribution and dosimetry', 'description': 'PET imaging will begin at 30s (30s/bed), 15min (1 min/bed), 30min (2 min/bed), 60min (2 min/bed) and 120min (2 min/bed) after injection, and whole-body low-dose CT needed to be re-acquired at 120 minutes', 'interventionNames': ['Drug: 68Ga-FAP-CHX']}, {'type': 'EXPERIMENTAL', 'label': 'Part II: diagnostic efficacy', 'description': 'Participants with various types of cancer will have PET imaging 50-100 minutes after injection of 68Ga-FAP-CHX and another agent (68Ga-FAPI-04 or 18F-FDG).', 'interventionNames': ['Drug: 68Ga-FAP-CHX']}], 'interventions': [{'name': '68Ga-FAP-CHX', 'type': 'DRUG', 'description': 'The dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging', 'armGroupLabels': ['Part I: safety, tolerability, biodistribution and dosimetry']}, {'name': '68Ga-FAP-CHX', 'type': 'DRUG', 'otherNames': ['68Ga-FAPI-04', '18F-FDG'], 'description': '68Ga-FAP-CHX, the dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging； 68Ga-FAPI-04, the dose will be 1.8 (MBq / kg) +/- 10% given intravenously at a single time prior to imaging； 18F-FDG, the dose will be 3.7 (MBq / kg) +/- 10% given intravenously at a single time prior to imaging；', 'armGroupLabels': ['Part II: diagnostic efficacy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350005', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weibing Miao, MD', 'role': 'CONTACT', 'email': 'miaoweibing@126.com', 'phone': '059187981618'}, {'name': 'Jie Zang, MD', 'role': 'CONTACT', 'email': '15901495106@163.com', 'phone': '15901495106'}], 'facility': 'Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Weibing Miao, MD', 'role': 'CONTACT', 'email': 'miaoweibing@126.com', 'phone': '86-0591-87981618'}, {'name': 'Jie Zang, MD', 'role': 'CONTACT', 'email': '15901495106@163.com', 'phone': '15901495106'}], 'overallOfficials': [{'name': 'Weibing Miao, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital, Fujian Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Fujian Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Nuclear Medicine Department', 'investigatorFullName': 'Weibing Miao, PhD', 'investigatorAffiliation': 'First Affiliated Hospital of Fujian Medical University'}}}}