Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT05814835
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2023-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
First in Human Study of 68Ga/64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-19', 'studyFirstSubmitDate': '2023-03-03', 'studyFirstSubmitQcDate': '2023-04-03', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': '7 days following injection', 'description': 'Evaluation of Adverse Events (AE) Using CTCAE'}], 'secondaryOutcomes': [{'measure': 'The diagnostic efficacy of 68Ga/64Cu-FAPI-XT injection in PET/CT imaging of patients with malignant solid tumor', 'timeFrame': '2 months following injection', 'description': 'Accuracy (AC), sensitivity (SE), specificity (SP), positive predictive value (PPV)'}, {'measure': "Change in 'treatment strategy questionnaire'", 'timeFrame': '2 months following injection', 'description': 'Referring physicians were asked to complete and return 2 questionnaires. The first assessed the existing treatment plan for the patient without the information from 68Ga/64Cu-FAPI-XT PET. The second inquired about intended management after receipt of the written clinical report and the 68Ga/64Cu-FAPI-XT PET images.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['68Ga-FAPI 64Cu-FAPI'], 'conditions': ['Malignant Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is the first-in-human study of 68Ga/64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.', 'detailedDescription': '20 patients with confirmed diagnosis of malignant solid tumor by histopathology or clinical judgment and required routine 18F-FDG PET/CT imaging were recruited. 68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient in any order(the interval was more than one day and less than four weeks). They were assigned to three 68Ga/64Cu-FAPI-XT117 dose groups, including 3±10% mCi、5±10% mCi and 7 ±10% mCi. PET/CT images were acquired 30min, 60min, 120min after injection. The primary end point was safety, secondary endpoints were accuracy (AC), sensitivity (SE), specificity (SP), positive predictive value (PPV), and change in management. Exploring end point was image quality, including qualitative and quantitative evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. signed the informed consent\n* 2\\. ≥18 years old\n* 3\\. confirmed as malignant solid tumor by histopathology or clinical judgment\n* 4\\. Patients will undergo 18F-FDG PET/CT examination\n\nExclusion Criteria:\n\n* 1\\. Known allergy to components of the investigational drug or its analogues\n* 2\\. suspected to have a certain disease or condition that is not suitable for the study drug\n* 3\\. Known pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT05814835', 'briefTitle': 'First in Human Study of 68Ga/64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'First in Human Study of 68Ga/64Cu-FAPI-XT117 PET/CT in Patients With Malignant', 'orgStudyIdInfo': {'id': 'XT-XTR016-1-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga/64Cu-FAPI-XT117 PET/CT', 'description': 'Each patient will receive 2-4 mCi, 4-6 mCi or 6-8 mCi 68Ga/64Cu-FAPI-XT117 intravenously (IV), and then PET/CT scanning within the specified time. On another day, patients receive 18F-FDG and then undergo PET/ CT.', 'interventionNames': ['Drug: 2-4 mCi 68Ga/64Cu-FAPI-XT117', 'Drug: 4-6 mCi 68Ga/64Cu-FAPI-XT117', 'Drug: 6-8 mCi 68Ga/64Cu-FAPI-XT117']}], 'interventions': [{'name': '2-4 mCi 68Ga/64Cu-FAPI-XT117', 'type': 'DRUG', 'description': '68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 2-4 mCi 68Ga/64Cu-FAPI-XT117 injection.', 'armGroupLabels': ['68Ga/64Cu-FAPI-XT117 PET/CT']}, {'name': '4-6 mCi 68Ga/64Cu-FAPI-XT117', 'type': 'DRUG', 'description': '68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 4-6 mCi 68Ga/64Cu-FAPI-XT117 injection.', 'armGroupLabels': ['68Ga/64Cu-FAPI-XT117 PET/CT']}, {'name': '6-8 mCi 68Ga/64Cu-FAPI-XT117', 'type': 'DRUG', 'description': '68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 6-8 mCi 68Ga/64Cu-FAPI-XT117 injection.', 'armGroupLabels': ['68Ga/64Cu-FAPI-XT117 PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100023', 'city': 'Beijing', 'country': 'China', 'facility': 'the First Medical Center, Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Ruimin Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'the First Medical Center, Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sinotau Pharmaceutical Group', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief of nuclear medicine department', 'investigatorFullName': 'Ruimin Wang', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}