Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-27 @ 2:00 PM
Study NCT ID:
NCT06690957
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2024-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Somatostatin Receptor PET/CT in SSTR-Related Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2024-11-14', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standardized uptake value (SUV)', 'timeFrame': '30 days', 'description': 'Standardized uptake value (SUV) of tracers for each target lesion of subject or suspected primary tumor or/and metastasis.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic efficacy', 'timeFrame': '30 days', 'description': 'The sensitivity, specificity and accuracy of SSTR-PET/CT were calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PET/CT', 'SSTR', 'Angonist', 'Antagonist'], 'conditions': ['SSTR-related Disease', 'Tumor', 'Positron Emission Tomography', 'Metastasis']}, 'referencesModule': {'references': [{'pmid': '40259061', 'type': 'DERIVED', 'citation': 'Yu H, Bao X, Gu Y, Pan M, He Q, Li D, Chen Q, Yao S. Comparison of PET/CT using 68Ga-NOTA-Exendin-4 with 68Ga-DOTATATE, 18F-FDG, and conventional imaging in the localization of insulinomas. Eur J Nucl Med Mol Imaging. 2025 Sep;52(11):4102-4111. doi: 10.1007/s00259-025-07288-x. Epub 2025 Apr 22.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the potential usefulness of 68Ga/18F-TATE/JR11/LM3 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various SSTR-related disease patients.', 'detailedDescription': 'Subjects with various SSTR-related disease patients underwent 68Ga/18F-TATE/JR11/ LM3 PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-TATE/JR11/LM3 PET/CT were calculated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '(i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled SSTR PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled SSTR PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.\n\nExclusion Criteria:\n\n\\- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT06690957', 'briefTitle': 'Somatostatin Receptor PET/CT in SSTR-Related Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University'}, 'officialTitle': 'Somatostatin Receptor PET/CT in SSTR-Related Disease Patients', 'orgStudyIdInfo': {'id': 'TJMUGH-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diagnostic Test: Single Group Assignment', 'description': 'Each subject receive a single intravenous injection of 68Ga/18F-TATE/JR11/LM3 , and undergo PET/CT imaging within the specificed time.', 'interventionNames': ['Diagnostic Test: 68Ga/18F-TATE/JR11/LM3']}], 'interventions': [{'name': '68Ga/18F-TATE/JR11/LM3', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each subject receive a single intravenous injection of 68Ga/18F-TATE/JR11/LM3, and undergo PET/CT imaging within the specificed time.', 'armGroupLabels': ['Diagnostic Test: Single Group Assignment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haonan Yu, MD', 'role': 'CONTACT', 'email': 'dreamadam@126.com', 'phone': '+8613821000597'}], 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Haonan Yu, MD', 'role': 'CONTACT', 'email': 'dreamadam@126.com', 'phone': '+8613821000597'}, {'name': 'Shaobo Yao, PhD', 'role': 'CONTACT', 'email': 'yaoshaobo008@163.com', 'phone': '+8615122570279'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Shaobo Yao, PhD', 'investigatorAffiliation': 'Tianjin Medical University'}}}}