Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-11 @ 12:06 PM
Study NCT ID:
NCT06344832
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SSTR PET/CT for Preoperative N Stage Evaluation in GEP-NETs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2030-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-28', 'studyFirstSubmitDate': '2024-03-28', 'studyFirstSubmitQcDate': '2024-03-28', 'lastUpdatePostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lymph node metastasis status', 'timeFrame': '2024.04.01~2030.03.01', 'description': 'lymph node metastasis status confirmed by histopathology'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastro-entero-pancreatic Neuroendocrine Tumor']}, 'descriptionModule': {'briefSummary': 'The research aims to prospectively include patients with GEP-NENs, undergo preoperative imaging assessment (including PET/CT and contrast-enhanced CT), and accurately delineate lymph node regions. Through postoperative pathological reports, the diagnostic performance of lymph node metastasis (LNM) in GEP-NENs is evaluated. Factors influencing the diagnostic accuracy of SSTR-PET/CT and contrast-enhanced CT are also investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with GEP-NEN undergoing surgical treatment at Peking Union Medical College Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 18 years old;\n2. Patients diagnosed with GEP-NEN by surgical pathology;\n3. Complete medical records including basic information and treatment process;\n4. Patients who have undergone preoperative contrast-enhanced CT and 68Ga-SSTR-PET/CT, and have consented to the 68Ga-SSTR-PET/CT project in the Nuclear Medicine Department.\n\nExclusion Criteria:\n\n1. Presence of concomitant malignancies;\n2. Cases diagnosed pathologically as non-GEP-NEN.'}, 'identificationModule': {'nctId': 'NCT06344832', 'briefTitle': 'SSTR PET/CT for Preoperative N Stage Evaluation in GEP-NETs', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Somatostatin Receptor Antagonist PET/CT for Pre-operative N Stage Evaluation in Patients With Gastro-entero-pancreatic Neuroendocrine Tumors', 'orgStudyIdInfo': {'id': 'K5098'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}