Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT07067905
Status:
RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of [68Ga]Ga-XT771 PET for Diagnosis in Patients With Glioblastoma and Clear Cell Renal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2025-07-07', 'studyFirstSubmitQcDate': '2025-07-07', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': '7 days following injection', 'description': 'Evaluation of Adverse Events (AE) Using CTCAE'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['clear cell renal cell carcinoma', 'glioblastoma', 'CAIX', 'CAXII', 'XT771'], 'conditions': ['Clear Cell Renal Cell Carcinoma and Glioblastoma']}, 'descriptionModule': {'briefSummary': 'A prospective, open-label, phase 1 study. This clinical trial aims to evaluate the diagnostic value of 68Ga-XT771, a CAIX/CAXII protein-specific probe, in PET/CT imaging for patients with clear cell renal cell carcinoma and glioblastoma. Safety, tolerability, and biodistribution characteristics of 68Ga-XT771 will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. signed the informed consent 2. ≥18 years old 3. Patients with glioblastoma or clear cell renal cell carcinoma\n\nExclusion Criteria:\n\n* 1\\. Known allergy to components of the investigational drug or its analogues 2. suspected to have a certain disease or condition that is not suitable for the study drug 3. Known pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT07067905', 'briefTitle': 'Clinical Evaluation of [68Ga]Ga-XT771 PET for Diagnosis in Patients With Glioblastoma and Clear Cell Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Clinical Evaluation of [68Ga]Ga-XT771 PET for Diagnosis in Patients With Glioblastoma and Clear Cell Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'S2025-149-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participant Group', 'description': 'Experimental: 68Ga-XT771 Subjects with suspected or confirmed clear cell renal cell carcinoma will receive an intravenous injection of 68Ga-XT771followed by PET imaging. The subjects will also receive a 18F-FDG PET/CT or 68Ga-DPI-4552 scan within a four-week period.\n\nPathologically confirmed glioblastoma subjects will receive intravenous administration of the CAIX/CAXII-targeted probe 68Ga-XT771, followed by PET imaging. Additionally, 11C-METHIONINE (11C-MET) PET scanning will be performed within a 4-week window\n\nDrug: 68Ga-XT771 68Ga-XT771 is injected intravenously with a dose of 4-8 mCi', 'interventionNames': ['Drug: 68Ga-XT771']}], 'interventions': [{'name': '68Ga-XT771', 'type': 'DRUG', 'description': '68Ga-XT771 is injected intravenously with a dose of 4-8 mCi', 'armGroupLabels': ['Participant Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ruimin Wang', 'role': 'CONTACT', 'email': 'wrm@yeah.net', 'phone': '+8613501151740'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ruimin Wang', 'role': 'CONTACT', 'email': 'wrm@yeah.net', 'phone': '+8613501151740'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sinotau Pharmaceutical Group', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chinses PLA General Hospital, nuclear medicine department', 'investigatorFullName': 'Ruimin Wang', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}