Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-31 @ 4:32 PM
Study NCT ID:
NCT05448404
Status:
UNKNOWN
Last Update Posted:
2022-07-08
First Post:
2022-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Head-to-head Comparative Study of 18F-PSMA-1007 PET/CT and 18F-FDG PET/CT Imaging in Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}], 'ancestors': [{'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '18F-PSMA-1007 PET/CT and 18F-FDG PET/CT Imaging completed within one week in the same patients.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-06', 'studyFirstSubmitDate': '2022-07-03', 'studyFirstSubmitQcDate': '2022-07-03', 'lastUpdatePostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of myeloma lesions', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'comparing the number of myeloma lesions detected by 18F-PSMA-1007 and 18F-FDG PET'}], 'secondaryOutcomes': [{'measure': 'standardized uptake value (SUV) of myeloma lesions', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'comparing the SUVmax of myeloma lesions derived from 18F-PSMA-1007 and 18F-FDG PET/CT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Prostate specific membrane antigen', 'fluorodeoxyglucose', 'positron emission tomography/Computed Tomography'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'Multiple myeloma (MM) is the second most common hematological malignancy and is still incurable. Positron emission tomography/computed tomography (PET/CT) has been used to diagnose, assess treatment response, and predict prognosis in MM. 18F-fluorodeoxyglucose (FDG) is the most widely used radiotracer, but there is heterogeneous uptake in MM, that is, uptake is negative in some myeloma cells. There are currently reports of cases with strong uptake of prostate-specific membrane antigen (PSMA) PET/CT in MM. Therefore, this preliminary study was designed to compare the imaging results of 18F-PSMA-1007 PET/CT and 18F-FDG PET/CT, and to evaluate the additional value of 18F-PSMA-1007 PET/CT to 18F-FDG PET/CT in MM.', 'detailedDescription': '18F-fluorodeoxyglucose (FDG) PET/CT can identify bone lesions, assess disease burden, and detect extramedullary lesions in multiple myeloma(MM), but due to MM is a complex and heterogeneous disease , 18F-FDG PET/CT has heterogeneous uptake in MM bone lesions, resulting in false negative results in the diagnosis of MM bone disease, then affecting the diagnosis, staging and evaluation of the response to treatment of MM. Prostate-specific membrane antigen (PSMA) is a specific membrane-bound glycoprotein, recently high uptake in PSMA PET/CT in MM bone lesions has been published in case reports, thus PSMA PET CT imaging may have potential value for multiple myeloma. There are no head-to-head studies comparing 18F-PSMA-1007 PET/CT with 18F-FDG PET/CT in multiple myeloma. Therefore, this study intends to compare the detection rate of lesions by 18F-PSMA-1007 PET/CT and 18F-FDG PET/CT in MM , and to evaluate the additional value of 18F-PSMA-1007 PET/CT to 18F-FDG PET/CT in multiple myeloma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed untreated or relapsed multiple myeloma patients;\n* 18F-PSMA-1007 and 18F-FDG PET/CT within one week;\n* signed written consent;\n* no combined other Malignant tumors.\n\nExclusion Criteria:\n\n* suffered from arthritis or combined with other malignant tumors;\n* received myeloma-related therapy within 3 months before PET/CT imaging\n* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.'}, 'identificationModule': {'nctId': 'NCT05448404', 'briefTitle': 'A Head-to-head Comparative Study of 18F-PSMA-1007 PET/CT and 18F-FDG PET/CT Imaging in Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'First Hospital of China Medical University'}, 'officialTitle': 'A Head-to-head Comparative Study of 18F-PSMA-1007 PET/CT and 18F-FDG PET/CT Imaging in Multiple Myeloma', 'orgStudyIdInfo': {'id': '37587411'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '18F-PSMA-1007 and 18F-FDG PET/CT scan', 'description': 'Patients of multiple myeloma PET/CT imaging: Within one week each patient underwent a PET/CT scan 60-min after intravenous administration of 18F-PSMA-1007 and 18F-FDG, respectively.', 'interventionNames': ['Drug: 18F-PSMA-1007', 'Drug: 18F-FDG']}], 'interventions': [{'name': '18F-PSMA-1007', 'type': 'DRUG', 'otherNames': ['18F-PSMA-1007 injection'], 'description': 'Intravenous injection of dosage of 222-370MBq(6-10mCi) 18F-PSMA-1007.', 'armGroupLabels': ['18F-PSMA-1007 and 18F-FDG PET/CT scan']}, {'name': '18F-FDG', 'type': 'DRUG', 'otherNames': ['18F-FDG injection'], 'description': 'Intravenous injection of dosage of 222-370MBq(6-10mCi) 18F-FDG.', 'armGroupLabels': ['18F-PSMA-1007 and 18F-FDG PET/CT scan']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuena Li, MD', 'role': 'CONTACT', 'email': 'lixuenacmunm@163.com', 'phone': '86-13516035756'}, {'name': 'Ling Xu, MM', 'role': 'CONTACT', 'email': 'xzmcxl@163.com', 'phone': '86-18752118670'}], 'facility': 'The First Affiliated Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Xuena Li, MD', 'role': 'CONTACT', 'email': 'lixuenacmunm@163.com', 'phone': '86-13516035756'}, {'name': 'Ling Xu, MM', 'role': 'CONTACT', 'email': 'xzmcxl@163.com', 'phone': '86-18752118670'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Xuena Li', 'investigatorAffiliation': 'First Hospital of China Medical University'}}}}