Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-01 @ 8:31 PM
Study NCT ID:
NCT07102056
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-03
First Post:
2025-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18F-AlF-NOTA-Octreotide PET in 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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-16', 'size': 818374, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2025-07-28T03:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 152}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2025-07-08', 'studyFirstSubmitQcDate': '2025-07-28', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Prognostic Value of Baseline 18F-OC PET for Progression-Free Survival (PFS) in High-Risk Patients', 'timeFrame': 'through study completion, 3-4 years', 'description': 'This measure evaluates the association between baseline 18F-OC PET parameters (e.g., SUVmax, SUVmean, metabolic tumor volume \\[MTV\\], total lesion glycolysis \\[TLG\\]) and progression-free survival (PFS) in high-risk neuroendocrine neoplasms patients. PFS will be defined as the time from diagnosis to disease progression or relapse, assessed using the Kaplan-Meier method and Cox proportional hazards model.'}], 'primaryOutcomes': [{'measure': 'Diagnostic efficacy', 'timeFrame': 'through study completion, an average of 1.5 year', 'description': 'Sensitivity, specificity, positive and negative predictive value of 18F-OC PET/CT and PET/MR Imaging in neuroendocrine neoplasms'}]}, 'conditionsModule': {'conditions': ['Neuroendocrine Tumors']}, 'descriptionModule': {'briefSummary': 'The study aims to elucidate how 18F-Octreotide PET/CT or PET-MR can assist in accurate localization, treatment planning, prognostic predictions, and the selection of PRRT efficacy in neuroendocrine tumors. It also highlights important applications in lesion segmentation measurement, tumor grading, prognostic survival prediction, and genotype identification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a previous diagnosis of neuroendocrine tumors who are suspected of recurrence or metastasis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosed of neuroendocrine neoplasms.\n2. Suspected of neuroendocrine neoplasms.\n\nExclusion Criteria:\n\n1. Inability to undergo biopsy/surgical treatment.\n2. Concurrent active malignancy.\n3. Severe uncontrolled comorbidities/active infections.\n4. Inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT07102056', 'briefTitle': '18F-AlF-NOTA-Octreotide PET in Neuroendocrine Neoplasms', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Zhejiang University'}, 'officialTitle': 'Prospective Study of 18F-AlF-NOTA-Octreotide PET-CT or PET-MR in Diagnosis, Treatment and Prognosis for Neuroendocrine Neoplasms', 'orgStudyIdInfo': {'id': 'FirstZhejiangU-18OC-NENs'}}, 'armsInterventionsModule': {'interventions': [{'name': '18F-AlF-NOTA-Octreotide PET-CT or PET-MR', 'type': 'DIAGNOSTIC_TEST', 'description': '18F-Octreotide PET/CT or PET/MR And enhanced CT or MR Imaging'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Donghe Chen', 'role': 'CONTACT', 'email': 'chendonghe@zju.edu.cn', 'phone': '0571-87236432'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}