Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 8:38 AM
Study NCT ID:
NCT06719856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MMP14(MT1-MMP) Targeting Bicyclic Peptide Probe for PET Imaging in Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}], 'ancestors': [{'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-24', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standardized uptake value（SUV）', 'timeFrame': '2 years', 'description': 'SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions. The uptake of the tracer （68Ga-MMP14） in solid tumor lesions by measuring SUV on PET/CT.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['solid tumor', 'MMP14', 'MT1-MMP', 'PET imaging'], 'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to construct a noninvasive approach using 68Ga-labeled bicyclic peptide radiotracer to detect the matrix metalloproteinase 14 (MMP14, MT1-MMP) expression of tumor lesions in patients with solid tumors and to identify patients benefiting from MMP14 targeting treatment.', 'detailedDescription': 'Analysis plan: 1. Recruit 3-5 participants to analyze preliminary pharmacokinetic/first-in-human dose (FIH), major organ distribution, and tumor uptake information via whole-body PET/CT imaging; 2. Recruit 20-30 participants to analyze in vivo safety and tumor targeting information; 3. Recruit all participants for a final summary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Malignant tumor patients or suspected patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Malignant melanoma, glioma, lung cancer, colon cancer, pancreatic cancer, gastric cancer, breast cancer, liver cancer, etc., confirmed by histopathology or cytology;\n2. age ≥18 and ≤75 years old, male or female;\n3. ECOG score 0 or 1;\n4. expected survival time ≥6 months;\n5. There was at least one measurable target lesion according to RECIST1.1 criteria, and biopsy could be performed within one month before and after PET scan, and the patient could provide 2-3 lesion tissue slides;\n6. Women of childbearing age (15-49 years) must have had a negative pregnancy test within 7 days before starting testing; Women and men of childbearing potential must agree to use effective contraception to avoid pregnancy during the study and for 3 months after the examination;\n7. patients recommended by clinicians to undergo PET/CT examination for tumor staging;\n8. The subjects could fully understand and voluntarily participate in this experiment, and signed an informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women, or women planning to become pregnant during the study or within three months after administration, as well as individuals donating sperm or oocytes.\n2. Individuals known or suspected to be allergic to the investigational drug or any of its components.\n3. Individuals with significantly abnormal liver or kidney function: serum total bilirubin (TBIL) \\> 1.5 × 20 µmol/L, or aspartate aminotransferase (AST) \\> 2.5 × 45 µmol/L, or alanine aminotransferase (ALT) \\> 2.5 × 40 µmol/L, or serum creatinine \\> 1.5 × 130 µmol/L.\n4. Unable to cooperate in completing the PET scan, or suffering from claustrophobia or other conditions that prevent cooperation during the PET scan.\n5. Other situations deemed inappropriate for participation in the trial by the investigator. Female patients who are pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT06719856', 'briefTitle': 'MMP14(MT1-MMP) Targeting Bicyclic Peptide Probe for PET Imaging in Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': 'MMP14(MT1-MMP) Targeting Bicyclic Peptide Probe for PET Imaging in Solid Tumors', 'orgStudyIdInfo': {'id': '2024YJZ143'}}, 'armsInterventionsModule': {'armGroups': [{'label': '68Ga-MMP14', 'description': 'All enrolled participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-MMP14 PET/CT scan.', 'interventionNames': ['Drug: 18-FDG']}], 'interventions': [{'name': '18-FDG', 'type': 'DRUG', 'description': 'All study participants will undergo one 18F-FDG PET/ CT scan.', 'armGroupLabels': ['68Ga-MMP14']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Hua Zhu', 'role': 'CONTACT', 'email': 'zhuhuabch@pku.edu.cn', 'phone': '010-88196495'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hua Zhu', 'role': 'CONTACT', 'email': 'zhuhuabch@pku.edu.cn', 'phone': '010-88196495'}, {'name': 'Zhi Yang', 'role': 'CONTACT', 'email': 'pekyz@163.com', 'phone': '010-88196196'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}