Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-03-11 @ 10:38 PM
Study NCT ID:
NCT06688305
Status:
RECRUITING
Last Update Posted:
2024-11-14
First Post:
2024-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
68Ga-NI-FAPI PET/CT: First-in-human Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2024-11-12', 'studyFirstSubmitQcDate': '2024-11-12', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Diagnostic value', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Sensitivity and Specificity of 68Ga-NI-FAPI for patients with various cancers.'}], 'primaryOutcomes': [{'measure': 'safety and tolerability', 'timeFrame': 'up to 1 week', 'description': 'Hematologic status, liver function, renal function and General vital signs were recorded before and 1 week after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.'}], 'secondaryOutcomes': [{'measure': 'Dosimetry of normal organs and tumors', 'timeFrame': 'From right after tracer injection to 150 minutes at post-injection', 'description': 'The semiquantitative dosimetry will be performed based on PET/CT acquisitions after the first administration of 68Ga-NI-FAPI. The dose delivered to normal organs and tumors will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Neoplasm']}, 'referencesModule': {'references': [{'pmid': '41168395', 'type': 'DERIVED', 'citation': 'Zang J, Cheng H, Luo Y, Jin W, Lai Y, Zheng Q, Peng Y, Kung HF, Zhu L, Ke C, Liu C, Miao W. First-in-human study of a novel bifunctional PET tracer [68Ga]Ga-DOTA-NI-FAPI-04 targeting FAP and hypoxia. Eur J Nucl Med Mol Imaging. 2025 Oct 31. doi: 10.1007/s00259-025-07625-0. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': '68Ga-NI-FAPI is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI PET/CT in patients with different types of cancer.', 'detailedDescription': "Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, and showed high efficacy in tumor staging and restaging. 68Ga-NI-FAPI is a novel agent incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI in patients with different types of cancer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Various solid tumors with available histopathological findings\n* Signed informed consent\n\nExclusion Criteria:\n\n* pregnant or lactational women\n* who suffered from severe hepatic and renal insufficiency'}, 'identificationModule': {'nctId': 'NCT06688305', 'briefTitle': '68Ga-NI-FAPI PET/CT: First-in-human Study', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Fujian Medical University'}, 'officialTitle': '68Ga-NI-FAPI PET/CT: First-in-human Study in Patients With Various Cancers', 'orgStudyIdInfo': {'id': 'FirstAHFujian-68Ga-NI-FAPI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-NI-FAPI PET/CT', 'description': 'PET/CT imaging in patients with malignant tumors: each patient underwent a PET/CT scan after intravenous administration of 68Ga-NI-FAPI.', 'interventionNames': ['Drug: 68Ga-NI-FAPI']}], 'interventions': [{'name': '68Ga-NI-FAPI', 'type': 'DRUG', 'description': 'Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-NI-FAPI.', 'armGroupLabels': ['68Ga-NI-FAPI PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350005', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Zang, PhD, MD', 'role': 'CONTACT', 'email': '15901495106@163.com', 'phone': '86-0591-87981619'}, {'name': 'Weibing Miao, MD', 'role': 'CONTACT', 'email': 'miaoweibing@126.com', 'phone': 'MD 86-0591-87981618'}], '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': '+86-0591-87981619'}], 'overallOfficials': [{'name': 'Weibing Miao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Fujian Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Fujian Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}