Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 9:14 PM
Study NCT ID:
NCT04422457
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2020-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Specific Molecular Imaging of DX600 Labeled by PET Radionuclide Targeting ACE2 in Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-16', 'studyFirstSubmitDate': '2020-06-05', 'studyFirstSubmitQcDate': '2020-06-05', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SUV', 'timeFrame': '2 years', 'description': 'The uptake of uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value（SUV）'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor']}, 'referencesModule': {'references': [{'pmid': '36198565', 'type': 'DERIVED', 'citation': 'Zhang Q, Liu T, Ding J, Zhou N, Yu Z, Ren Y, Qin X, Du P, Yang Z, Zhu H. Evaluation of 68Ga- and 177Lu-Labeled HZ20 Angiotensin-Converting Enzyme 2-Targeting Peptides for Tumor-Specific Imaging. Mol Pharm. 2022 Nov 7;19(11):4149-4156. doi: 10.1021/acs.molpharmaceut.2c00541. Epub 2022 Oct 5.'}]}, 'descriptionModule': {'briefSummary': 'Angiotensin-converting enzyme 2 (ACE2) plays an important role in renin-angiotensin system (RAS) and has been reported to relate with cancer. Recently, it has also been proved as the key target for COVID-19 infection.\n\nDX600 is a polypeptide that can specific binding to ACE2 specifically with nanomolar affinity reported in literature. This study constrcuted a radio-tracer, DX600 Labeled by PET Radionuclide, to monitoring biodistribution ACE2 in human beings, evaluate the detection ability of radio-tracer in ACE2 over-expression tumors and dynamic changes of ACE2 expression under therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75 years old; both sex;\n* ECoG 0 or 1;\n* Patients that would undergo biopsy or surgical operation with high ACE2 expression tumors such as colorectal cancer, renal cancer, pancreatic cancer, gastric cancer, liver cancer, lung cancer, brain cancer or suspected tumor.\n* use 18F-FDG PET/CT as baseline evaluation\n\nExclusion Criteria:\n\n* Significant hepatic or renal dysfunction;\n* Is Pregnant or ready to pregnant;\n* Cannot lie on their back for half an hour;\n* Suffering from claustrophobia or other mental diseases;\n* Refusal to join the clinical study;'}, 'identificationModule': {'nctId': 'NCT04422457', 'briefTitle': 'Specific Molecular Imaging of DX600 Labeled by PET Radionuclide Targeting ACE2 in Patients', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': 'Specific Molecular Imaging of DX600 Labeled by PET Radionuclide Targeting ACE2 in Patients', 'orgStudyIdInfo': {'id': '2020KT62'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imaging cohort', 'description': 'All study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-DX600 PET/CT scans', 'interventionNames': ['Other: 68Ga-DX600 PET/CT']}], 'interventions': [{'name': '68Ga-DX600 PET/CT', 'type': 'OTHER', 'description': 'DX600, labeled with 68Ga will be used as a molecular imaging tracer for PET/CT scanning', 'armGroupLabels': ['Imaging cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Ethics Committee of Peking University Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Hua Zhu', 'investigatorAffiliation': 'Peking University Cancer Hospital & Institute'}}}}