Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-01-05 @ 5:19 PM
Study NCT ID:
NCT03511768
Status:
UNKNOWN
Last Update Posted:
2018-04-30
First Post:
2018-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of 18F-AlF-NOTA-octreotide PET/CT for Imaging Neuroendocrine Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711267', 'term': 'Al18F-NOTA-octreotide'}, {'id': 'D000072078', 'term': 'Positron Emission Tomography Computed Tomography'}], 'ancestors': [{'id': 'D049268', 'term': 'Positron-Emission Tomography'}, {'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D064847', 'term': 'Multimodal Imaging'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-17', 'studyFirstSubmitDate': '2018-04-17', 'studyFirstSubmitQcDate': '2018-04-17', 'lastUpdatePostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '18F-AlF-NOTA-octreotide PET/CT imaging of patients with Neuroendocrine Neoplasms', 'timeFrame': '12 months', 'description': 'The radioligand 18F-AlF-NOTA-octreotide can be used to visualize neuroendocrine neoplasms'}], 'secondaryOutcomes': [{'measure': '18F-AlF-NOTA-octreotide PET/CT prognostic factor for overall and disease specific survival', 'timeFrame': '24 months', 'description': 'The uptake of the 18F-AlF-NOTA-octreotide in neuroendocrine neoplasm lesions (quantified as Standard Uptake Values) is associated with overall and disease specific free survival (PFS) neuroendocrine neoplasms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['18F-AlF-NOTA-octreotide'], 'conditions': ['Neuroendocrine Neoplasm']}, 'referencesModule': {'references': [{'pmid': '20150268', 'type': 'RESULT', 'citation': 'Laverman P, McBride WJ, Sharkey RM, Eek A, Joosten L, Oyen WJ, Goldenberg DM, Boerman OC. A novel facile method of labeling octreotide with (18)F-fluorine. J Nucl Med. 2010 Mar;51(3):454-61. doi: 10.2967/jnumed.109.066902. Epub 2010 Feb 11.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the clinical value of \\[18F\\]aluminum fluoride-1,4,7-triazacyclononane-1,4,7-triacetic acid-octreotide（18F-AlF-NOTA-octreotide ） positron emission tomography / computed tomography (PET/CT) in patients with neuroendocrine neoplasms (NENs).', 'detailedDescription': '18F-AlF-NOTA-octreotide is a radioligand targeting the somatostatin receptor, which is widely expressed on the cell surface of NENs. The radioligand can be used for the diagnosis and stage of the NENs. A total of 5 volunteers and 60 NEN patients will be subjected to a 18F-AlF-NOTA-octreotide PET/CT scan. The uptake of 18F-AlF-NOTA-octreotide in organs and tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically and/or clinically confirmed and/or suspicious of NEN.\n2. Signed informed consent.\n\nExclusion Criteria:\n\n1. Claustrophobia (unable to accept PET/CT scanning)\n2. Pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT03511768', 'briefTitle': 'A Study of 18F-AlF-NOTA-octreotide PET/CT for Imaging Neuroendocrine Neoplasms', 'organization': {'class': 'OTHER', 'fullName': 'Xiangya Hospital of Central South University'}, 'officialTitle': 'A Study of 18F-AlF-NOTA-octreotide PET/CT for Imaging Neuroendocrine Neoplasms', 'orgStudyIdInfo': {'id': '201801001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '18F-AlF-NOTA-octreotide PET/CT', 'description': 'One injection of the radioligand 18F-AlF-NOTA-octreotide', 'interventionNames': ['Drug: 18F-AlF-NOTA-octreotide', 'Device: PET/CT']}], 'interventions': [{'name': '18F-AlF-NOTA-octreotide', 'type': 'DRUG', 'otherNames': ['18F-IMP466'], 'description': 'One injection of 18F-AlF-NOTA-octreotide', 'armGroupLabels': ['18F-AlF-NOTA-octreotide PET/CT']}, {'name': 'PET/CT', 'type': 'DEVICE', 'description': 'Following injection of 18F-AlF-NOTA-octreotide the participants will be subjected to whole body PET/CT', 'armGroupLabels': ['18F-AlF-NOTA-octreotide PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tingting Long, MD,Phd', 'role': 'CONTACT', 'email': 'longtingting@csu.edu.cn', 'phone': '+86 13549682646'}], 'facility': 'Department of PET Center,Xiangya Hospital,Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Tingting Long, MD,Phd', 'role': 'CONTACT', 'email': 'longtingting@csu.edu.cn', 'phone': '+86 13549682646'}, {'name': 'Shuo Hu, professor', 'role': 'CONTACT', 'email': 'hushuo_xy@163.com', 'phone': '+86 15874210819'}], 'overallOfficials': [{'name': 'Tingting Long, MD,Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of PET Center,Xiangya Hospital, Central South University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}