A Prospective, Multicenter, Diagnostic Study Evaluating 68Ga-BCMA PET/CT for Targeting BCMA Expression in Multiple Myeloma.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Safety of BCMA-targeted radiotracer
研究概览
简要总结
This is a prospective, multicenter diagnostic imaging study designed to evaluate the diagnostic accuracy and clinical utility of BCMA-targeted positron emission tomography/computed tomography (PET/CT) in patients with multiple myeloma and related plasma cell disorders. The study aims to non-invasively visualize and quantify whole-body BCMA expression and to assess its role in the detection of active disease and disease heterogeneity.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with suspected or previously diagnosed multiple myeloma (MM) who were scheduled for bone marrow aspiration or tissue biopsy within two weeks, including those undergoing initial diagnostic evaluation or follow-up/re-evaluation for disease monitoring or relapse;
- •patients with confirmed symptomatic MM;
- •ability to understand and voluntarily sign written informed consent;
- •ability to comply with study procedures;
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
排除标准
- •pregnancy or lactation;
- •inability to comprehend study procedures or cooperate with protocol requirements;
- •any other condition judged by the investigator to potentially interfere with study participation.
研究组 & 干预措施
68Ga-BCMA PET/CT
Every patient will receive 68Ga-BCMA PET/CT
干预措施: 68Ga-BCMA PET/CT (Diagnostic Test)
结局指标
主要结局
Safety of BCMA-targeted radiotracer
时间窗: 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.
Diagnostic performance of 68Ga-BCMA PET/CT
时间窗: From enrollment to the end of PET/CT at 4 weeks
To determine the diagnostic accuracy of BCMA PET/CT for detecting active myeloma lesions, using biopsy confirmation as the reference standard.
次要结局
- Correlation Between Lesion uptake on BCMA PET/CT and Disease Burden Markers(Within 2 weeks of PET/CT imaging)
- Detection of extramedullary disease(Baseline imaging assessment.)
- Impact on clinical management(Within 30 days after imaging.)