PET Imaging Study of 68Ga-NB381 in Multiple Myeloma - Trial NCT06385652

Timeline & Enrollment

Primary Outcome

Specificity and Binding Efficiency of 68Ga-NB381 in CD38 Positive Tumors

Summary

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.

ICD-10 Classifications