Application Study of 68Ga-NOTA-BCMA Nanoantibody Imaging in Multiple Myeloma

Multiple myeloma is a malignant plasma cell disorder. Real-time dynamic monitoring of the development, progression, and treatment response of myeloma remains an unmet clinical need. The development of a novel non-invasive in vivo detection technique is essential and holds significant importance for improving the prognosis of myeloma patients. Nuclear medicine plays a crucial role in the diagnosis, staging, treatment, and follow-up of multiple myeloma. The commonly used clinical nuclear imaging method, 18F-FDG PET/CT, has certain limitations in detecting myeloma lesions. B-cell maturation antigen (BCMA) is a target that is highly and specifically expressed on the surface of myeloma cells. The 68Ga-labeled nanobody targeting BCMA demonstrates high specificity in detecting myeloma lesions. Compared to traditional antibody-based probes, it offers advantages such as a simpler structure, lower molecular weight, and higher stability, showing promise as a novel non-invasive molecular imaging technique for myeloma evaluation and guiding individualized treatment. Our research group has completed the preparation, labeling, and quality control of the 68Ga-NOTA-BCMA nanobody molecular probe, as well as preclinical studies on its pharmacokinetics, pharmacodynamics, and safety evaluation.In this prospective study, patients diagnosed with multiple myeloma were enrolled to undergo 68Ga-BCMA nanobody imaging before treatment, followed by a repeat scan after treatment, to analyze its detection rate and correlation with clinical tumor burden.

Inclusion criteria

• Newly diagnosed or relapsed MM patients
• Written informed consent obtained and capable of undergoing follow-up.

Exclusion criteria

• Severely abnormal liver and kidney function
• Women who are planning pregnancy, are pregnant, or are breastfeeding, as well as those with childcare plans during the study period; subjects of childbearing potential must use effective contraceptive measures throughout the study.
• Individuals unable to lie flat for 30 minutes.
• Individuals who decline to participate in this clinical study.
• Patients with claustrophobia or other psychiatric disorders, or poor compliance that may compromise their ability to cooperate with the study procedures.
• Other circumstances deemed by the investigator as unsuitable for participation in this clinical trial.