Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-27 @ 7:33 AM
Study NCT ID:
NCT05581550
Status:
COMPLETED
Last Update Posted:
2025-07-20
First Post:
2021-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Somatostatin Receptor Imaging in NPC, EBV Related Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2021-12-09', 'studyFirstSubmitQcDate': '2022-10-13', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of tracer uptake in the tumour lesions of NPC patients', 'timeFrame': 'From time of tracer injection to time the scan is performed', 'description': 'The maximum standardized uptake values (SUVmax) will be measured. If the average SUVmax of all the lesions is more than 10, the patient will be considered to have an overall high somatostatin receptor density.'}], 'secondaryOutcomes': [{'measure': 'Amount of tracer uptake in the tumour lesions of patients with EBV related cancers', 'timeFrame': 'From time of tracer injection to time the scan is performed', 'description': 'The maximum standardized uptake values (SUVmax) will be measured. If the average SUVmax of all the lesions is more than 10, the patient will be considered to have an overall high somatostatin receptor density.'}, {'measure': 'Number of somatostatin receptors in patient biopsy samples', 'timeFrame': 'Upon signing the informed consent form'}, {'measure': 'Amount of somatostatin circulating tumour cells in patient blood samples', 'timeFrame': 'At the time of scan'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Somatostatin', 'EBV', 'NPC', 'Rare Cancer'], 'conditions': ['Nasopharyngeal Cancer', 'Epstein-Barr Virus Related Carcinoma']}, 'descriptionModule': {'briefSummary': 'The study aims to describe the avidity of somatostatin receptors in locally advanced, metastatic and locally recurrent nasopharyngeal cancer (NPC) and to determine the proportion of NPC patients with high somatostatin receptor density that may benefit from future somatostatin targeted therapeutic trial plans. The investigators also aim to determine the presence of somatostatin receptors in other EBV related cancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Locally advanced, metastatic or locally recurrent NPC that are going for FDG PET as part of their investigations\n* Patients that have gone for Ga-68 DOTATATE imaging before are eligible for repeat imaging\n* Histologically confirmed NPC\n* Above 21 years of age\n\nExclusion Criteria:\n\n* Patients below 21 years of age\n* Pregnant and breast feeding ladies'}, 'identificationModule': {'nctId': 'NCT05581550', 'briefTitle': 'Somatostatin Receptor Imaging in NPC, EBV Related Cancers', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Centre, Singapore'}, 'officialTitle': 'Somatostatin Receptor Imaging in Nasopharyngeal Cancer, Epstein-Barr Virus (EBV) Related Cancers and Other Rare Tumors', 'orgStudyIdInfo': {'id': 'NPC EBV SSTR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PET imaging', 'interventionNames': ['Radiation: FDG-PET', 'Radiation: Galium-68 DOTATATE']}], 'interventions': [{'name': 'FDG-PET', 'type': 'RADIATION', 'description': 'Patients will be fasted for 6 hours prior to intravenous injection of 370MBq +/- 10% (18)F-fluorodeoxyglucose. Scanning will be performed at an interval of at least 60 minutes following the injection.', 'armGroupLabels': ['PET imaging']}, {'name': 'Galium-68 DOTATATE', 'type': 'RADIATION', 'description': '200MBq +/- 10% Galium-68 DOTATATE will be injected intravenously. Scanning will be performed approximately 60 minutes after the injection.', 'armGroupLabels': ['PET imaging']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Cancer Centre Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Wen Long Nei, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Centre, Singapore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Centre, Singapore', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Centre Research Fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}