Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 3:27 AM
Study NCT ID:
NCT07442292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PD-L1 Targeting Peptide Probe for PET Imaging of Solid Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-02-24', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MPR', 'timeFrame': '3-6 months', 'description': 'major pathological response, in the surgical pathology after neo-adjuvant immunotherapy, the proportion of active tumors was less than 10%.'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': '3-6 months', 'description': 'Overall Response Rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer (NSCLC)', 'Lung Cancer (SCLC)', 'Melanoma (Skin Cancer)', 'Melanoma Metastatic', 'PD-L1', 'PET / CT']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to construct a noninvasive approach using radiolabbled peptide 68Ga-cPP-BCH PET/CT to detect the PD-L1 expression of tumor lesion in patients with lung cancer, melanoma and other solid tumor to identify patients benefiting from anti-PD-(L)1 treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with lung cancer, melanoma or other solid tumors scheduled for immunotherapy or combined immunotherapy; underwent PD-L1 IHC examination before therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18-75, male and female, with ECOG score of 0 or 1;\n2. Subjects with lung cancer, melanoma, or other solid tumors scheduled for immunotherapy or combined immunotherapy;\n3. underwent PD-L1 IHC examination before therapy;\n4. The expected survival was more than 26 weeks;\n5. Blood routine test, liver and kidney function meet the following standards: blood routine: WBC \\>= 4.0 x 10\\^9/L or neutrophil \\>= 1.5 x 10\\^9/:, PLT \\>= 100 x 10\\^9 / L, Hb \\>= 90g / L; Pt or APTT \\<= 1.5 upper limit of normal value; liver and kidney function: total bilirubin \\<= 1.5 x ULT (upper limit of normal value), ALT / AST \\<= 2.5 upper limit of normal value or \\<= 5 x ULT (subject with liver metastasis), ALP \\<= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, ALP \\<= 4.5 upper limit of normal value); BUN \\<= 1.5 x ULT, SCR \\<= 1.5 x ULT;\n6. According to RECIST1.1, there was at least one measurable target lesion;\n7. Understand and sign informed consent voluntarily with good compliance.\n\nExclusion Criteria:\n\n1. The function of liver and kidney was seriously abnormal;\n2. Preparation for pregnant, pregnant and lactating women;\n3. Inability to lie flat for half an hour;\n4. Suffering from claustrophobia or other mental disorders;\n5. Other researchers considered it unsuitable to participate in the trial.'}, 'identificationModule': {'nctId': 'NCT07442292', 'briefTitle': 'PD-L1 Targeting Peptide Probe for PET Imaging of Solid Tumor', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': 'PD-L1 Targeting Peptide Probe 68Ga-cPP-BCH for PET Imaging of Solid Tumor', 'orgStudyIdInfo': {'id': '2026KT10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients take 68Ga-cPP-BCH PET/CT before and after therapy', 'description': 'Patients take paired baseline 18F-FDG PET/CT and 68Ga-cPP-BCH PET/CT within 1 week; and take 68Ga-cPP-BCH PET/CT after therapy'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hua Zhu, Professor', 'role': 'CONTACT', 'email': 'zhuhuabch@pku.edu.cn', 'phone': '+86-010-88196495'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hua Zhu', 'investigatorAffiliation': 'Peking University Cancer Hospital & Institute'}}}}