This study intends to employ 68Ga-NOTA-BCMA nanobody PET/CT imaging in patients with multiple myeloma to evaluate the feasibility of this technique for myeloma assessment, analyze the correlation between 68Ga-NOTA-BCMA nanobody uptake intensity and disease staging, tumor burden, and prognosis, explore its value in assessing treatment response and predicting early relapse, and compare its detection rate for myeloma lesions with that of 18F-FDG PET/CT. The results of this study may provide a more sensitive and specific imaging diagnostic method for patients with multiple myeloma and offer a basis for the individualized selection of future BCMA-targeted therapies. This study has been approved by the Ethics Committee of Peking Union Medical College Hospital.
Newly diagnosed or relapsed MM patients
Written informed consent obtained and capable of undergoing follow-up.
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.
Single group
68Ga-BCMA nanobody PET/CT
Diagnostic testOn the day of the examination (fasting is not required), an intravenous injection of the 68Ga-NOTA-BCMA nanobody will be administered, followed by PET/CT imaging approximately 0.5 to 1 hour later.
18F-FDG PET/CT
Diagnostic testWithin 1 to 2 weeks, 18F-FDG PET/CT imaging will be performed, which requires an intravenous injection of 18F-FDG (fasting for at least 4 hours is required) followed by PET/CT imaging approximately 1 hour later.
Detection rate of 68Ga-BCMA nanobody PET/CT
The number of patients with positive BCMA PET results was counted and divided by the total number of individuals who completed BCMA PET imaging to calculate the detection rate of BCMA PET.
Survival
The time to progression (TTP) in follow-up patients was analyzed using the log-rank test for survival analysis to examine the association between baseline BCMA PET positivity and TTP.
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