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GPRC5D Targeted PET/CT Imaging in Plasma Cell Disorders

2026年6月16日 更新者：Peking University First Hospital

A Single-Center, Phase I, Single-Arm Prospective Interventional Study of GPRC5D-Targeted PET/CT Imaging in Patients With Multiple Myeloma and Other Plasma Cell Disorders

This is a prospective, single-center, single-arm Phase I study evaluating GPRC5D-targeted PET/CT imaging in patients with plasma cell disorders, including multiple myeloma.

Participants will undergo GPRC5D-targeted PET/CT, 18F-FDG PET/CT, and 68Ga-BCMA PET/CT within 5 days whenever feasible for head-to-head comparison of lesion detection and disease assessment.

The study aims to evaluate the safety, feasibility, biodistribution, and diagnostic performance of GPRC5D-targeted PET/CT and to compare its imaging characteristics with currently available molecular imaging modalities in plasma cell disorders.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This is a prospective, single-center, single-arm Phase I interventional imaging study designed to evaluate the safety, feasibility, biodistribution, and diagnostic performance of GPRC5D-targeted PET/CT imaging in patients with plasma cell disorders, including multiple myeloma.

GPRC5D is a novel therapeutic and molecular imaging target that is highly expressed on malignant plasma cells while showing limited expression in normal tissues. Recent advances in GPRC5D-targeted immunotherapies have demonstrated promising clinical activity in multiple myeloma, highlighting the potential value of GPRC5D-directed molecular imaging for disease detection, tumor burden evaluation, treatment selection, therapeutic response assessment and prognostic evaluation.

Current standard molecular imaging with 18F-FDG PET/CT has several limitations in multiple myeloma, including reduced sensitivity in lesions with low hexokinase-2 expression and limited specificity due to inflammatory uptake.Therefore, development of novel imaging approaches targeting alternative plasma cell antigens may improve disease evaluation and provide complementary biological information.

In this study, eligible participants will undergo GPRC5D-targeted PET/CT imaging together with standard molecular imaging examinations, including 18F-FDG PET/CT and 68Ga-BCMA PET/CT. Whenever feasible, all imaging studies will be completed within 5 days to minimize interval changes in disease status and enable direct head-to-head comparison among imaging modalities.

Imaging findings from GPRC5D-targeted PET/CT will be compared with 18F-FDG PET/CT and 68Ga-BCMA PET/CT with respect to lesion detectability, disease distribution, tumor uptake characteristics, and overall disease assessment. The study will also evaluate tracer biodistribution, radiation dosimetry, image quality, and safety of the GPRC5D-targeted radiotracer.

The results of this study may help establish GPRC5D-targeted PET/CT as a novel molecular imaging tool for plasma cell disorders and support future development of GPRC5D-directed theranostic strategies in multiple myeloma.

研究类型

介入性

注册 (估计的)

50

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国
        • Peking University First Hospital
        • 首席研究员：
          • Lei Kang, M.D, Ph.D
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Adults with confirmed or suspected plasma cell disorders, including multiple myeloma.
  • Healthy volunteers eligible for PET/CT imaging may also be enrolled.
  • Availability of recent clinical laboratory results within 1 week prior to imaging, when applicable.
  • Ability to undergo PET/CT imaging procedures.
  • Ability to understand the study requirements and provide written informed consent.

Exclusion Criteria:

  • History of other active malignant tumors, unless considered clinically insignificant by the investigator.
  • Pregnant or breastfeeding women.
  • Inability to understand study procedures or comply with imaging examinations.
  • Any medical or psychiatric condition that, in the investigator's judgment, may interfere with study participation or image interpretation.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

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
实验性的：GPRC5D PET/CT Imaging With Comparator PET/CT Studies
Participants with plasma cell disorders, including multiple myeloma, will undergo GPRC5D-targeted PET/CT imaging following intravenous administration of the investigational GPRC5D-targeted radiotracer. Participants will also undergo 18F-FDG PET/CT and 68Ga-BCMA PET/CT within 5 days whenever feasible for intra-individual head-to-head comparison of lesion detection and disease assessment. Safety, biodistribution, tracer uptake characteristics, and imaging performance will be evaluated.
诊断测试：GPRC5D-Targeted PET/CT Imaging
Participants with plasma cell disorders, including multiple myeloma, will undergo GPRC5D-targeted PET/CT imaging following intravenous administration of the investigational GPRC5D-targeted radiotracer. Participants will also undergo 18F-FDG PET/CT and 68Ga-BCMA PET/CT within 5 days whenever feasible for intra-individual head-to-head comparison of lesion detection and disease assessment. Safety, biodistribution, tracer uptake characteristics, and imaging performance will be evaluated.

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
Diagnostic Accuracy of GPRC5D-Targeted PET/CT for Detection of Disease Lesions
大体时间：Within 5 days after completion of all PET/CT imaging examinations
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and inter-reader agreement between independent readers for identification of disease lesions in participants with plasma cell disorders, compared with standard reference assessments and with 18F-FDG PET/CT and 68Ga-BCMA PET/CT.
Within 5 days after completion of all PET/CT imaging examinations
Incidence and Severity of Adverse Events Following GPRC5D-Targeted Radiotracer Administration
大体时间：From radiotracer administration to 30 days after PET/CT imaging
Number of participants experiencing adverse events and severity of adverse events following administration of the GPRC5D-targeted radiotracer, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
From radiotracer administration to 30 days after PET/CT imaging

次要结果测量

结果测量
措施说明
大体时间
Concordance Between Imaging Findings and Clinical Disease Assessment
大体时间：From imaging to 1 months of clinical follow-up
Concordance between GPRC5D-targeted PET/CT findings and clinical, laboratory, and conventional imaging assessments of disease status.
From imaging to 1 months of clinical follow-up
Tumor-to-Background Ratio on GPRC5D-Targeted PET/CT
大体时间：At the time of image interpretation within 5 days after imaging
Tumor-to-background ratio (TBR), maximum standardized uptake value (SUVmax), and mean standardized uptake value (SUVmean) of disease lesions identified on GPRC5D-targeted PET/CT.
At the time of image interpretation within 5 days after imaging

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Peking University First Hospital

调查人员

  • 首席研究员：Lei Kang, M.D, Ph.D、Peking University First Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月25日

初级完成 (估计的)

2027年5月25日

研究完成 (估计的)

2027年5月25日

研究注册日期

首次提交

2026年6月8日

首先提交符合 QC 标准的

2026年6月16日

首次发布 (实际的)

2026年6月22日

研究记录更新

最后更新发布 (实际的)

2026年6月22日

上次提交的符合 QC 标准的更新

2026年6月16日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026R0036-0002

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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