Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-30 @ 4:39 PM
Study NCT ID:
NCT05930457
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2023-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of 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': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-19', 'studyFirstSubmitDate': '2023-06-26', 'studyFirstSubmitQcDate': '2023-06-26', 'lastUpdatePostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Uptake of the 64Cu-FAPI-XT and optimal scanning specifications for future studies', 'timeFrame': 'From first dose of imaging study drug through two hours post dose'}, {'measure': 'Determine impact of administered dose of 64Cu-FAPI-XT on image quality', 'timeFrame': 'From first dose of imaging study drug through two hours post dose'}], '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 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 64Cu-FAPI-XT PET. The second inquired about intended management after receipt of the written clinical report and the 64Cu-FAPI-XT PET images.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is the study of 64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, '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': 'NCT05930457', 'briefTitle': 'Study of 64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'Study of 64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors', 'orgStudyIdInfo': {'id': 'XT-XTR016-1-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '64Cu-FAPI-XT117 PET/CT', 'interventionNames': ['Drug: 2.5-3.5mCi 64Cu-FAPI-XT117', 'Drug: 3.5-4.5mCi 64Cu-FAPI-XT117', 'Drug: 4.5-5.5mCi 64Cu-FAPI-XT117']}], 'interventions': [{'name': '2.5-3.5mCi 64Cu-FAPI-XT117', 'type': 'DRUG', 'description': '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 2.5-3.5mCi 64Cu-FAPI-XT117 injection.', 'armGroupLabels': ['64Cu-FAPI-XT117 PET/CT']}, {'name': '3.5-4.5mCi 64Cu-FAPI-XT117', 'type': 'DRUG', 'description': '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 3.5-4.5mCi 64Cu-FAPI-XT117 injection.', 'armGroupLabels': ['64Cu-FAPI-XT117 PET/CT']}, {'name': '4.5-5.5mCi 64Cu-FAPI-XT117', 'type': 'DRUG', 'description': '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 4.5-5.5mCi 64Cu-FAPI-XT117 injection.', 'armGroupLabels': ['64Cu-FAPI-XT117 PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'country': 'China', 'facility': 'The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sinotau Pharmaceutical Group', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief of nuclear medicine department', 'investigatorFullName': 'Xinlu Wang', 'investigatorAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}}}}