Development of a Novel Peptide-Based PET Tracer [68Ga]Ga-DOTA-BP1 for BCMA Detection in Multiple Myeloma.
Lele Song, Sujun Jiang, Qi Yang...
https://pubmed.ncbi.nlm.nih.gov/39167092/Actively Recruiting
Led by Peking University First Hospital · Updated on 2026-06-22
300
Participants Needed
5
Research Sites
N/A
Total Duration
Researchers are evaluating the use of BCMA-targeted positron emission tomographycomputed tomography PETCT scans in patients with multiple myeloma and related plasma cell disorders. This prospective, multicenter diagnostic imaging study aims to visualize and measure BCMA expression throughout the body, helping to detect active disease and its variations. The study focuses on how this imaging method may provide valuable clinical information across different disease states. Participants will receive the 68Ga-labeled BCMA PETCT imaging through an intravenous injection of a BCMA-targeted radiotracer followed by a whole-body scan following a standardized protocol. Imaging results will be compared with biopsy findings when possible to assess accuracy. The study will also explore relationships between PETCT findings and other clinical, laboratory, and imaging markers, including minimal residual disease assessments. Some participants will have blood samples taken to measure circulating soluble BCMA levels, providing additional biological context. During the study, participants will undergo the PETCT imaging and may have biopsies and blood tests as part of assessments. Researchers will analyze imaging findings alongside clinical and laboratory data to understand disease burden and response. Safety of the radiotracer will be monitored for up to 30 days after injection. Follow-up will assess changes in imaging over time and the impact on clinical management. The study is expected to last until December 2027 and includes adults aged 18 to 80 years.
CONDITIONS
68Ga-BCMA PET/CT in Multiple Myeloma
L
Lei Kang, M.D, Ph.D
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Peking University First Hospital
Lead Sponsor
The First Hospital of Jilin University
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 4 weeks
Participants undergo the 68Ga-BCMA PET/CT imaging, including intravenous injection of the radiotracer followed by a whole-body scan. Biopsies may be performed when clinically feasible to confirm findings.
1 visit for imaging and possible biopsy
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Lele Song, Sujun Jiang, Qi Yang...
https://pubmed.ncbi.nlm.nih.gov/39167092/Tingfei Gu, Zhao Chen, Tianyao Wang...
https://pubmed.ncbi.nlm.nih.gov/41239440/Tianyao Wang, Qi Yang, Wenpeng Huang...
https://pubmed.ncbi.nlm.nih.gov/40558019/Peking University First Hospital
Lead Sponsor
The First Hospital of Jilin University
Collaborating Sponsor