protocolSection identificationModule nctId: NCT06385652, orgStudyIdInfo id: PekingUFH-MM-NB381, briefTitle: PET Imaging Study of 68Ga-NB381 in Multiple Myeloma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Peking University First Hospital, class: OTHER, descriptionModule briefSummary: Multiple myeloma (MM) predominantly affects the elderly, often presenting insidiously and with a rising incidence rate. Current diagnostic methods primarily rely on invasive bone marrow biopsies, which can lead to false-negative results if the biopsy site is improperly chosen. CD38 is significantly overexpressed on the surface of malignant plasma cells in MM, making it a characteristic tumor biomarker for this disease.Addressing the limitations in specificity and sensitivity of traditional PET imaging agents, this project is dedicated to developing a new type of nanobody PET/CT imaging probe, 68Ga-NB381, which possesses high affinity and targets CD38. This probe, which is an intellectual property of our institution, aims to enhance the accuracy and specificity of early MM diagnosis. In terms of clinical evaluation, the project will implement a comprehensive assessment process including case selection, collection of baseline information, high-precision imaging, expert-level image interpretation, and follow-up studies, comparing directly with traditional 18F-FDG imaging to thoroughly verify the specificity and safety of 68Ga-NB381. This lays the groundwork for the clinical translation of this radiopharmaceutical in China. Furthermore, the project contributes to formulating more effective precision treatment plans based on CD38 expression levels and provides evidence for monitoring the therapeutic effects of daratumumab, a drug also targeting CD38. This makes the project of significant academic value and clinical importance, thus promoting the development of personalized treatment strategies., conditionsModule conditions: Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: In this sequential assignment clinical trial, we aim to evaluate and compare the diagnostic performance of two PET imaging agents, 68Ga-NB381 and 18F-FDG, in patients diagnosed with multiple myeloma (MM). The study will enroll MM patients who meet the inclusion criteria and are scheduled for routine diagnostic imaging.Each participant will undergo PET imaging with 18F-FDG first, followed by a second PET scan using 68Ga-NB381 (or reversed). To minimize potential interference between the two imaging sessions and ensure patient safety, a minimum interval of one day will be maintained between the two scans, with all imaging completed within one week. This sequential imaging approach allows for direct comparison of the imaging agents in the same patient, thus controlling for inter-patient variability and providing a more accurate assessment of the relative merits of each imaging agent in the same metabolic and pathological condition., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, maskingDescription: All PET/CT images are jointly interpreted by at least two imaging and nuclear medicine physicians, each with several years of diagnostic experience and at least at the attending physician level. They compare and record the number of lesions detected and the SUVs (Standard Uptake Values) for both 18F-FDG and 68Ga-NB381 PET/CT scans. After consultation, they provide a unified diagnostic opinion., enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: 68Ga-NB381, outcomesModule primaryOutcomes measure: Specificity and Binding Efficiency of 68Ga-NB381 in CD38 Positive Tumors, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University First Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100000, country: China, contacts name: Ronghui Yu, Master, role: CONTACT, phone: +8613466379791, email: kyc@bjmu.edu.cn, contacts name: Lei Kang, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: TIANYAO Wang, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Yongkang Qiu, Master, role: SUB_INVESTIGATOR, contacts name: Zhenghao Tong, MD, role: SUB_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False