一项前瞻性、多中心诊断研究，评估68Ga-BCMA PET/CT用于靶向多发性骨髓瘤中BCMA的表达。
一项前瞻性、多中心、诊断性研究，评估68Ga-BCMA PET/CT对多发性骨髓瘤中BCMA表达的靶向作用。
研究概览
详细说明
This study is a prospective, multicenter diagnostic imaging investigation designed to evaluate the clinical value of BCMA-targeted positron emission tomography/computed tomography (PET/CT) in patients with multiple myeloma and related plasma cell disorders across different disease states.
Participants will undergo 68Ga-labeled BCMA PET/CT imaging in accordance with a standardized imaging protocol. Imaging findings will be assessed for the presence, distribution, and intensity of BCMA expression at both lesion-based and patient-based levels. Where clinically feasible, imaging findings will be correlated with histopathologic confirmation obtained from biopsy, which will serve as the reference standard for evaluation of diagnostic accuracy.
In addition to lesion detection, this study will explore the relationship between BCMA PET/CT findings and established clinical, laboratory, and imaging parameters. These include conventional imaging modalities, indicators of disease burden, and minimal residual disease (MRD) assessments when available. Longitudinal clinical follow-up will be conducted to assess changes in imaging findings over time and their association with treatment response and disease status.
In a subset of participants, circulating soluble BCMA (sBCMA) levels will be measured in peripheral blood samples collected within a predefined time window around the time of PET/CT imaging. Exploratory analyses will be performed to evaluate the association between sBCMA levels, imaging-derived measures of BCMA expression, and other indicators of disease burden. These analyses are intended to provide complementary biological context for imaging findings and to explore the potential role of integrating imaging and blood-based biomarkers in the assessment of multiple myeloma.
By integrating advanced molecular imaging with clinical, pathological, and biological data, this study aims to characterize whole-body disease burden and heterogeneity in a non-invasive manner and to define the potential clinical utility of BCMA PET/CT for diagnosis, response assessment, and disease monitoring in multiple myeloma.
研究类型
注册 (估计的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Lei Kang, M.D, Ph.D
- 电话号码：86+13811486428
- 邮箱：kanglei@bjmu.edu.cn
学习地点
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Beijing Municipality
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Beijing、Beijing Municipality、中国
- 招聘中
- Peking University First Hospital
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接触：
- Tingfei Dr. Gu, M.D, Ph.D
- 电话号码：8618513338311
- 邮箱：tingfei.gu@ndm.ox.ac.uk
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首席研究员：
- Lei Kang, M.D, Ph.D
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首席研究员：
- Yujun Dong, M.D, Ph.D
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Beijing、Beijing Municipality、中国
- 招聘中
- Beijing Tsinghua Changgung Hospital
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接触：
- Lihong Li, M.D, Ph.D
- 电话号码：86 135 0139 0152
- 邮箱：llha03032@btch.edu.cn
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首席研究员：
- Lihong Li, M.D, Ph.D
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Beijing、Beijing Municipality、中国
- 招聘中
- Beijing An Zhen Hospital of the Capital University of Medical Sciences
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接触：
- Yini Wang, M.D, Ph.D
- 电话号码：8613901086559
- 邮箱：wangyini@ccmu.edu.cn
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首席研究员：
- Yini Wang, M.D, Ph.D
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Hebei
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Shijiazhuang、Hebei、中国
- 招聘中
- The Second Hospital of Hebei Medical University
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接触：
- Fuxu Wang, M.D, Ph.D
- 电话号码：8613931100360
- 邮箱：wfxhebmu@163.com
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首席研究员：
- Fuxu Wang, M.D, Ph.D
-
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Jilin
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Jilin City、Jilin、中国
- 招聘中
- First Hospital of Jilin University
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接触：
- Fengyan Jing
- 电话号码：8613844989638
- 邮箱：fengyanjin@jlu.edu.cn
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首席研究员：
- Fengyan Jing, M.D, Ph.D
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
纳入标准：
（1）疑似或先前诊断为多发性骨髓瘤（MM）的患者，计划在两周内进行骨髓穿刺或组织活检，包括接受初次诊断评估或随访/重新评估以进行疾病监测或复发的患者；（2）确诊为有症状MM的患者；（3）能够理解并自愿签署书面知情同意书；（4）能够遵守研究程序；（5）东部肿瘤协作组（ECOG）体能状态≤2。
排除标准：
怀孕或哺乳期；无法理解研究程序或配合方案要求；或研究者判断可能干扰研究参与的任何其他情况。
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：68Ga-BCMA PET/CT
每位患者都将接受68Ga-BCMA PET/CT检查
|
静脉注射研究性BCMA靶向放射性药物，随后按照标准化方案进行全身PET/CT扫描。
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
68Ga-BCMA PET/CT的诊断性能
大体时间：从入组至4周PET/CT检查结束
|
为确定BCMA PET/CT检测活动性骨髓瘤病灶的诊断准确性，使用活检确认作为参考标准。
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从入组至4周PET/CT检查结束
|
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Safety of BCMA-targeted radiotracer
大体时间：Up to 30 days after tracer injection.
|
Number of participants experiencing adverse events and severity of adverse events following administration of the BCMA-targeted radiotracer, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
|
Up to 30 days after tracer injection.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation Between Lesion uptake on BCMA PET/CT and Disease Burden Markers
大体时间：Within 2 weeks of PET/CT imaging
|
Spearman correlation coefficients between lesion uptake on BCMA PET/CT and disease burden markers, including serum M-protein concentration, soluble BCMA levels, involved free light chain level, and bone marrow plasma cell percentage.
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Within 2 weeks of PET/CT imaging
|
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Detection of extramedullary disease
大体时间：Baseline imaging assessment.
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Baseline imaging assessment.
|
|
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Impact on clinical management
大体时间：Within 30 days after imaging.
|
Proportion of patients whose treatment strategy changed following BCMA-targeted PET/CT findings.
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Within 30 days after imaging.
|
合作者和调查者
合作者
调查人员
- 首席研究员：Lei Kang, M.D, Ph.D、Peking University First Hospital
- 首席研究员：Yujun Dong, M.D, Ph.D、Peking University First Hospital
出版物和有用的链接
一般刊物
- Song L, Jiang S, Yang Q, Huang W, Qiu Y, Chen Z, Sun X, Wang T, Wu S, Chen Y, Zeng H, Wang Z, Kang L. Development of a Novel Peptide-Based PET Tracer [68Ga]Ga-DOTA-BP1 for BCMA Detection in Multiple Myeloma. J Med Chem. 2024 Sep 12;67(17):15118-15130. doi: 10.1021/acs.jmedchem.4c00759. Epub 2024 Aug 21.
- Wang T, Yang Q, Huang W, Sun X, Lei Y, Xu H, Song L, Duan X, Liu F, Wang W, Bao Z, Gao J, Wang F, Kang L. Development and Preclinical Validation of a Novel 89Zr-Labeled BCMA-Targeting Antibody for ImmunoPET Imaging: Application in Multiple Myeloma Models and First-In-Nonhuman-Primates. J Med Chem. 2025 Jul 24;68(14):14843-14858. doi: 10.1021/acs.jmedchem.5c01010. Epub 2025 Jun 25.
- Gu T, Chen Z, Wang T, Dong Y, Kang L. B-cell maturation antigen targeted PET/CT imaging in multiple myeloma: a first-in-human study. J Hematol Oncol. 2025 Nov 14;18(1):101. doi: 10.1186/s13045-025-01758-3.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PFBC01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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