Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-30 @ 9:36 AM
Study NCT ID:
NCT05442151
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2022-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2022-06-18', 'studyFirstSubmitQcDate': '2022-06-29', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the uptake on FAPI-PET with conventional imaging', 'timeFrame': 'Within 2 hours after administration of [F-18]FAPI-74 injection', 'description': 'Comparison of SUV (standardized uptake value) of primary site and metastatic lesions between FAPI-PET and FDG-PET'}, {'measure': 'Comparison with pathological specimens', 'timeFrame': 'Within one month after FAPI-PET', 'description': 'Comparison of expression level (staining score) in FAP immunostaining and SUV in FAPI-PET (FAP staining is graded by scoring evaluation: high expression (3 points), moderate expression (2 points), mild expression (1 point), and no significant expression (0 point).)'}, {'measure': 'Time course of uptake on FAPI-PET', 'timeFrame': 'Approximately 6 months after initial FAPI-PET', 'description': 'Time course of uptake on FAPI-PET before and after treatment compared with conventional imaging'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neoplasms']}, 'referencesModule': {'references': [{'pmid': '34420105', 'type': 'BACKGROUND', 'citation': 'Naka S, Watabe T, Lindner T, Cardinale J, Kurimoto K, Moore M, Tatsumi M, Mori Y, Shimosegawa E, Valla F Jr, Kato H, Giesel FL. One-pot and one-step automated radio-synthesis of [18F]AlF-FAPI-74 using a multi purpose synthesizer: a proof-of-concept experiment. EJNMMI Radiopharm Chem. 2021 Aug 21;6(1):28. doi: 10.1186/s41181-021-00142-z.'}]}, 'descriptionModule': {'briefSummary': 'PET / CT examination using \\[18F\\] FAPI-74 is performed on patients diagnosed with malignant tumor, and the pathological condition is determined by comparing with FDG-PET/CT examination of conventional diagnostic imaging.', 'detailedDescription': 'Cancer stroma accounts for more than 90% of all tumors, and cancer-related fibroblasts (CAFs) play an important role in the growth and progression of cancer. FAP expressed in CAF has been found to be expressed in many cancers, and \\[68Ga\\] FAPI-04 and \\[18F\\] FAPI-74, which are PET diagnostic agents for FAP ligand FAPI, have been used all over the world. The purpose of this study is to perform PET / CT using \\[18F\\] FAPI-74 injection for patients diagnosed with malignant tumors, mainly pancreatic cancer and gastric cancer to evaluate the pathology in detail by comparing with the FDG-PET/CT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients who meet any of the following conditions.\n\n1. Patients who have been diagnosed with malignant tumors or suspected of having malignant tumors and have CT or FDG-PET examination.\n2. Patients who have been diagnosed with malignant tumor and are scheduled to receive or have undergone anticancer treatment such as chemotherapy or radiation therapy.\n3. Patients suspected of recurrence by clinical findings or diagnostic imaging such as CT or FDG-PET after treatment of malignant tumor\n\nExclusion Criteria:\n\n1. Pregnant women or patients who may be pregnant\n2. Pediatric patients requiring sedation\n3. Those who are judged to be inappropriate as subjects.'}, 'identificationModule': {'nctId': 'NCT05442151', 'briefTitle': 'Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts', 'organization': {'class': 'OTHER', 'fullName': 'Osaka University'}, 'officialTitle': 'Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts', 'orgStudyIdInfo': {'id': '21472'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'FAPI-PET/CT group', 'interventionNames': ['Drug: PET/CT ([F-18]FAPI-74)']}], 'interventions': [{'name': 'PET/CT ([F-18]FAPI-74)', 'type': 'DRUG', 'description': 'PET/CT using \\[18F\\] FAPI-74 injection', 'armGroupLabels': ['FAPI-PET/CT group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '565-0871', 'city': 'Suita', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Tadashi Watabe, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'watabe@tracer.med.osaka-u.ac.jp', 'phone': '+81-6-6879-3461'}, {'name': 'Tadashi Watabe, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Osaka University Hospital', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}], 'centralContacts': [{'name': 'Tadashi Watabe, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'watabe@tracer.med.osaka-u.ac.jp', 'phone': '+81-6-6879-3461'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tadashi Watabe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Tadashi Watabe', 'investigatorAffiliation': 'Osaka University'}}}}