A Molecular Probe Targeting BCMA for the Clinical Diagnosis of Multiple Myeloma

Condition(s) studied

Investigational drug(s) / intervention(s)

18F-FDG: Prior to the examination, patients will be required to fast for at least 6 hours. 18F-FDG (0.05-0.1 mCi/kg) will be intravenously injected, and one hour after the injection, head and torso imaging will be performed using a Shanghai United Imaging uMI 780 PET/CT scanner, covering the region from the top of the head to the upper third of the thigh. The patient will lie supine and breathe calmly during the procedure. After image acquisition, the data will be reconstructed using the OSEM method to generate coronal, sagittal, transverse, and PET/CT fusion images.

68Ga-BC1: The prepared and quality-controlled 68Ga-BC1 (0.05-0.1 mCi/kg) will be intravenously injected into the patient. Two hours after the injection, whole-body imaging will be performed using a Shanghai United Imaging uMI 780 PET/CT scanner, covering the region from the top of the head to the mid-thigh. If any indeterminate lesions are found during the routine imaging, delayed imaging will be performed for further differentiation. The patient will lie supine and breathe calmly during the procedure. After image acquisition, the data will be reconstructed using the OSEM method to generate coronal, sagittal, transverse, and PET/CT fusion images.

Study summary

Multiple Myeloma (MM), the second most common hematological malignancy, continues to pose challenges in precise clinical identification. As a potential solution, nuclear medicine immuno-PET imaging has emerged as a promising approach. However, traditional full-length antibody probes suffer from delayed tumor uptake peaks and low target-to-background ratios, limiting their clinical utility. In our study, a peptide or nanobody targeting BCMA was developed by computer-aided designing, which was subsequently radiolabeled with 68Ga to create a novel molecular probe, 68Ga-MM-BC1. This research aims to overcome the diagnostic limitations of MM and may also offer valuable insights for molecular-targeted imaging in other malignant tumors.

Eligibility

Primary outcome measure(s)

• MM patients will be recruited to undergo PET/CT imaging using 68Ga-NB381 and 18F-FDG to evaluate and verify that the imaging agent 68Ga-NB381 can safely and effectively identify lesions. — All PET/CT images will be reviewed by physicians, and a unified diagnostic opinion will be provided within 3 days after adminis. After imaging, patients will be scheduled for follow-up visits every 3 months, with a follow-up period of at least 12 months.
  This study will investigate the radioactive uptake of 68Ga-BC1 in lesion sites of multiple myeloma patients and evaluate the ability of 68Ga-BC1 to detect BCMA overexpression in these patients. According to the admission and exclusion criteria, patients who meet the conditions are screened. After the patients were enrolled, baseline examination information was collected, including blood routine, blood biochemistry, tumour markers, histopathological diagnosis results, imaging diagnosis results, etc. For the Follow-up information, the patient's bone marrow aspirate or pathological tissue biopsy, laboratory test results (blood monoclonal M protein, 24-hour urine light chain, etc.), bone scintigraphy, CT or MR and other imaging examination results would be collected.

Trial sites (2)

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