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PET-Enabled Dual-Energy CT in Multiple Myeloma

2026年6月9日 更新者：University of California, Davis

PET-enabled Dual-energy CT for Oncological Applications

This pilot study will evaluate a new imaging method called PET-enabled dual-energy CT for measuring bone and soft-tissue composition in bone marrow. The study will enroll adults with multiple myeloma who are scheduled to receive CAR T-cell therapy and healthy adult participants.

All participants will undergo research imaging with dynamic 18F-FDG PET/CT and X-ray dual-energy CT. Participants with multiple myeloma will have imaging before CAR T-cell therapy and again after therapy. Healthy participants will have one imaging visit.

The main goal is to compare bone and soft-tissue fraction measurements from PET-enabled dual-energy CT with measurements from standard X-ray dual-energy CT. The study will also explore whether corrected PET measurements are associated with bone marrow measurable residual disease, treatment response, and CAR T-cell therapy toxicities in participants with multiple myeloma.

This study is not expected to provide direct medical benefit to participants. The information learned may help improve future PET/CT imaging methods for cancer evaluation.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This is a single-institution, prospective pilot study evaluating PET-enabled dual-energy CT (DECT) for quantitative bone marrow imaging. The study will enroll adults with multiple myeloma who are scheduled to receive CAR T-cell therapy and healthy adult participants for comparison.

PET-enabled DECT is an imaging method that uses data from a standard time-of-flight PET/CT scan to generate a high-energy attenuation image. This image is combined with the standard X-ray CT image to create a dual-energy image pair. The goal is to measure tissue composition, including bone fraction and soft-tissue fraction, without requiring dedicated dual-energy PET/CT hardware.

All participants will undergo research imaging with dynamic 18F-FDG PET/CT and X-ray DECT. Participants with multiple myeloma will undergo baseline imaging before CAR T-cell therapy and follow-up imaging after therapy. Healthy participants will undergo one imaging visit. Multiple myeloma participants will also have bone marrow measurable residual disease (MRD), treatment response, and CAR T-cell therapy toxicity data collected from standard clinical care or related clinical assessments.

The primary objective is to develop and validate the new DECT method for quantitatively measuring tissue compositions of bone marrow regions in multiple myeloma and healthy participants using X-ray DECT as the reference. Secondary objectives include: To determine whether bone fraction in bone marrow differs between MM patients and healthy participants and whether PET-enabled DECT can accurately estimate bone fraction for correcting PET-based bone-marrow metabolic measurements; and, to evaluate relationships between corrected PET measures and bone marrow MRD and treatment response and toxicities of CAR T-cell therapy in MM patients This study is exploratory and is designed to collect preliminary data to support future larger studies. The research imaging is not intended to guide clinical care, and participants are not expected to receive direct medical benefit from participation. The information learned may help improve quantitative PET/CT imaging methods for future cancer evaluation and treatment monitoring.

研究类型

介入性

注册 (估计的)

45

阶段

  • 不适用

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

学习地点

  • 美国
    • California
      • Sacramento、California、美国、95816

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:

For all research participants:

  • Adults (age ≥ 18 years old)
  • Ability to understand and willingness to sign an informed consent form
  • Ability to adhere to the study visit schedule and other protocol requirements.
  • Willing and able to fast for at least 6 hours before and for the duration of the scan
  • No strenuous exercise for 24 hours prior to being scanned
  • Willing to lie on the scanner bed for up to 60 minutes

For healthy volunteers only:

• Free of history of cardiovascular, inflammatory, infections or metabolic diseases that would result in changes in bone marrow.

For cancer patients only:

  • Patients with multiple myeloma who are planned to receive CAR T-cell therapy with any FDA-approved product, including Idecel and Ciltacel. Patients with prior chemo-immunotherapy are permitted.
  • Able to undergo bone marrow aspirate/biopsy procedure

Exclusion Criteria:

  • Self-reported history of dysphoria or anxiety in closed spaces
  • Body weight >240 kg due to limitations of the scanner bed
  • Pregnant or breast-feeding (due to risks of ionizing radiation; urine pregnancy test will be administered prior to start of each PET/CT session for all participants between 18 to 60 years old who are able to get pregnant, unless documented hysterectomy or bilateral ovarian removal is available)
  • Blood glucose greater than 200 as assessed by fingerstick method before injection of 18F-FDG
  • Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only. That is, PET scans are not performed as part of a patient's treatment plan (e.g. standard of care, therapeutic purposes, or clinical care) and the research study did not intend to provide therapeutic benefit to the patient.
  • Prisoners
  • Any condition that would prevent the understanding or rendering of informed consent.
  • Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives.

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：非随机化
  • 介入模型：并行分配
  • 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：Multiple Myeloma Participants
Adults with multiple myeloma who are scheduled to receive CAR T-cell therapy. Participants will undergo baseline dynamic 18F-FDG PET/CT and X-ray dual-energy CT imaging before CAR T-cell therapy. Participants will also undergo follow-up dynamic 18F-FDG PET/CT and X-ray dual-energy CT imaging after CAR T-cell therapy.
诊断测试：PET-enabled dual-energy CT imaging
18F-FDG will be administered intravenously for dynamic PET/CT imaging.
诊断测试：X-ray dual-energy CT imaging
Participants will undergo X-ray dual-energy CT imaging. Measurements from X-ray dual-energy CT will be used as the reference method for comparison with PET-enabled dual-energy CT measurements.
实验性的：Healthy Participants
Healthy adult participants without a history of cardiovascular, inflammatory, infectious, or metabolic diseases expected to affect bone marrow. Participants will undergo one dynamic 18F-FDG PET/CT and X-ray dual-energy CT imaging visit.
诊断测试：PET-enabled dual-energy CT imaging
18F-FDG will be administered intravenously for dynamic PET/CT imaging.
诊断测试：X-ray dual-energy CT imaging
Participants will undergo X-ray dual-energy CT imaging. Measurements from X-ray dual-energy CT will be used as the reference method for comparison with PET-enabled dual-energy CT measurements.

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
Agreement between PET-enabled DECT and X-ray DECT measurements of bone marrow tissue fractions
大体时间：Baseline imaging visit; and for multiple myeloma participants, follow-up imaging at approximately Day +90 after CAR T-cell therapy initiation
Agreement between PET-enabled dual-energy CT and standard X-ray dual-energy CT will be assessed for quantitative bone fraction and soft-tissue fraction measurements in bone marrow regions.
Baseline imaging visit; and for multiple myeloma participants, follow-up imaging at approximately Day +90 after CAR T-cell therapy initiation

次要结果测量

结果测量
措施说明
大体时间
Difference in bone marrow bone fraction between multiple myeloma participants and healthy participants
大体时间：Baseline imaging visit
Bone fraction in bone marrow regions will be compared between participants with multiple myeloma and healthy participants using PET-enabled DECT and X-ray DECT measurements.
Baseline imaging visit
Corrected 18F-FDG standardized uptake value in bone marrow
大体时间：Baseline imaging visit; and for multiple myeloma participants, follow-up imaging at approximately Day +90 after CAR T-cell therapy initiation
Bone marrow 18F-FDG standardized uptake value will be corrected for bone fraction using PET-enabled DECT-derived tissue fraction measurements.
Baseline imaging visit; and for multiple myeloma participants, follow-up imaging at approximately Day +90 after CAR T-cell therapy initiation
Association between corrected PET measures and bone marrow measurable residual disease
大体时间：Baseline and follow-up assessments through approximately Day +90 after CAR T-cell therapy initiation
Corrected PET measures, including corrected standardized uptake value and kinetic parameters, will be evaluated for association with bone marrow measurable residual disease in multiple myeloma participants.
Baseline and follow-up assessments through approximately Day +90 after CAR T-cell therapy initiation
Association between corrected PET measures and CAR T-cell therapy response and toxicities
大体时间：Baseline imaging through approximately Day +90 after CAR T-cell therapy initiation
Corrected PET measures, including corrected bone marrow standardized uptake value and 18F-FDG kinetic parameters, will be evaluated for association with CAR T-cell therapy response and toxicities in participants with multiple myeloma.
Baseline imaging through approximately Day +90 after CAR T-cell therapy initiation

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

University of California, Davis

合作者

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

调查人员

  • 首席研究员：Guobao Wang, PhD、University of California, Davis

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7月1日

初级完成 (估计的)

2030年8月1日

研究完成 (估计的)

2030年11月1日

研究注册日期

首次提交

2026年6月9日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月15日

研究记录更新

最后更新发布 (实际的)

2026年6月15日

上次提交的符合 QC 标准的更新

2026年6月9日

最后验证

2026年6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

  • 2399411
  • 1R01EB036562-01 (美国 NIH 拨款/合同)

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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