Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:19 AM
Study NCT ID:
NCT07353333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-20
First Post:
2026-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preliminary Evaluation of Clinical Application of SPECT Imaging Targeting GPC3
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-19', 'studyFirstSubmitDate': '2026-01-11', 'studyFirstSubmitQcDate': '2026-01-19', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiation dose to human body', 'timeFrame': '1 year', 'description': 'Metric/method of measurement：Use OLINDA/EXM software'}], 'secondaryOutcomes': [{'measure': 'Region of Interest,ROI', 'timeFrame': '1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HCC', 'SPECT-CT']}, 'descriptionModule': {'briefSummary': 'This project will target patients with highly clinically suspected or histopathology diagnosed hepatocellular carcinoma (HCC) using targeted GPC3-specific imaging agents (e.g. , Iodine-131-aGPC3-Scfv) for integrated SPECTCT imaging, to evaluate the pharmacokinetics distribution of the targeted drug in patients with hepatocellular carcinoma (HCC) by low-dose integrated diagnosis and treatment (i.e. , Iodine-131-RRB- imaging, to determine the metabolism, safety and tolerability of the drug in vivo Secondary objective: to evaluate the targeting of GPC3-SPECIFIC imaging agents in patients with hepatocellular carcinoma to assess the feasibility of this targeted agent for future treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. the subject or his/her legal representative can sign and date the informed consent form\n2. commitment to follow the research procedures and cooperate in the implementation of the full-process research\n3. patients with high clinical suspicion or histopathology diagnosis of HCC and generally in good condition\n4. patients with a history of hepatocellular carcinoma who recur after treatment\n5. women in their reproductive years were using contraception for at least one month before screening and were committed to using contraception throughout the study period and for the prescribed period after the end of the study\n\nExclusion Criteria:\n\n1. inability to complete SPECTCT examination (including inability to lie down, claustrophobia, radiophobia, etc.)\n2. acute systemic diseases and electrolyte disorders\n3. patients with known hypersensitivity to GPC3 imaging agents or synthetic excipients\n4. patients considered by the investigator to have poor adherence\n5. pregnant or lactating patients\n6. Have other factors not suitable to participate in this test'}, 'identificationModule': {'nctId': 'NCT07353333', 'briefTitle': 'Preliminary Evaluation of Clinical Application of SPECT Imaging Targeting GPC3', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'Preliminary Evaluation of Clinical Application of SPECT Imaging Targeting GPC3', 'orgStudyIdInfo': {'id': 'XLan-250923'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sPECT imaging targeting GPC3 in malignant tumors', 'description': 'Determine if targeting GPC3 SPECT is safe and effective method for imaging of malignant tumors.', 'interventionNames': ['Drug: 131I-aGPC3']}], 'interventions': [{'name': '131I-aGPC3', 'type': 'DRUG', 'description': 'Using targeted GPC3-specific imaging agents (e.g. , Iodine-131-aGPC3-Scfv) for integrated SPECTCT imaging, evaluate the pharmacokinetics distribution of the targeted drug in patients with hepatocellular carcinoma (HCC) by low-dose integrated diagnosis and treatment (i.e. , Iodine-131- imaging), and determine the metabolism, safety and tolerability of the drug in vivo', 'armGroupLabels': ['sPECT imaging targeting GPC3 in malignant tumors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': 'wenzhu P Xiaoli Lan, PhD', 'role': 'CONTACT', 'email': 'lxl730724@hotmail.com', 'phone': '0086-027-83692633'}, {'role': 'CONTACT', 'email': 'huwz2016@126.com'}], 'facility': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Xiaoli Lan, Xiaoli Lan', 'role': 'CONTACT', 'email': 'lxl730724@hotmail.com', 'phone': '0086-027-83692633'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}