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

Condition(s) studied

Investigational drug(s) / intervention(s)

68Ga-BCMA nanobody PET/CT: On 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: Within 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Detection rate of 68Ga-BCMA nanobody PET/CT — through study completion, an average of 1 year
  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.

Trial sites (1)

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