跳至主要内容
临床试验/NCT06630845
NCT06630845
招募中
不适用

Comparison of Whole Body DWI to FDG PET Using PET/MRI

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 30 人2025年2月6日

概览

阶段
不适用
干预措施
Fluorodeoxyglucose F18
疾病 / 适应症
Metastatic Cancer
发起方
University of California, San Francisco
入组人数
30
试验地点
1
主要终点
Proportion of lesions characterized as positive
状态
招募中
最后更新
29天前

概览

简要总结

This is a single arm prospective trial that evaluates whole body diffusion weight imaging (DWI) compared to 18F-fludeoxyglucose (FDG) Positron Emission Tomography with Magnetic resonance imaging (PET/MRI) in participants with known metastatic cancer.

详细描述

PRIMARY OBJECTIVE: I. Correlation of DWI and FDG to detect disease. SECONDARY OBJECTIVE: I. Inter-reader variability of DWI interpretation by region. OUTLINE: Participants will be imaged at a single timepoint using whole body DWI concurrent with FDG PET/MRI within 60 days of receiving a non-FDG PET (either PET/CT or PET/MRI). There will be an optional PET/MRI performed within six months of the original study. Participants will be followed up through a medical records review for up to two years.

注册库
clinicaltrials.gov
开始日期
2025年2月6日
结束日期
2029年10月31日
最后更新
29天前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

入排标准

入选标准

  • Age ≥ 18 years.
  • Non FDG PET imaging study scheduled to be performed within 60 days (before or after) of the research PET/MRI.
  • Ability to understand a written informed consent document, and the willingness to sign it.
  • Diagnosis of metastatic cancer.

排除标准

  • Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
  • Individuals with contraindications to MRI. This will be determined through review of the UCSF MRI screening form by qualified site personnel

研究组 & 干预措施

Whole Body DWI plus FDG PET/MRI

Participants will receive 5 to 10 Megabecquerel (MBq) +/- 10% of 18F-fluorodeoxyglucose as an intravenous injection and undergo a FDG PET/MRI scan that will extend from the vertex to the mid-thighs. Imaging will be performed from vertex to mid-thighs using standard protocol. Participants may also obtain an optional second FDG PET/MRI with DWI within 6 months.

干预措施: Fluorodeoxyglucose F18

Whole Body DWI plus FDG PET/MRI

Participants will receive 5 to 10 Megabecquerel (MBq) +/- 10% of 18F-fluorodeoxyglucose as an intravenous injection and undergo a FDG PET/MRI scan that will extend from the vertex to the mid-thighs. Imaging will be performed from vertex to mid-thighs using standard protocol. Participants may also obtain an optional second FDG PET/MRI with DWI within 6 months.

干预措施: Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI)

Whole Body DWI plus FDG PET/MRI

Participants will receive 5 to 10 Megabecquerel (MBq) +/- 10% of 18F-fluorodeoxyglucose as an intravenous injection and undergo a FDG PET/MRI scan that will extend from the vertex to the mid-thighs. Imaging will be performed from vertex to mid-thighs using standard protocol. Participants may also obtain an optional second FDG PET/MRI with DWI within 6 months.

干预措施: General Electric (GE) SIGNA PET/MR

Whole Body DWI plus FDG PET/MRI

Participants will receive 5 to 10 Megabecquerel (MBq) +/- 10% of 18F-fluorodeoxyglucose as an intravenous injection and undergo a FDG PET/MRI scan that will extend from the vertex to the mid-thighs. Imaging will be performed from vertex to mid-thighs using standard protocol. Participants may also obtain an optional second FDG PET/MRI with DWI within 6 months.

干预措施: Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI)

结局指标

主要结局

Proportion of lesions characterized as positive

时间窗: Up to 6 months

The overall proportion of lesions that will be characterized as positive on whole body (WB) diffusion weight imaging (DWI) and FDG PET.

次要结局

  • Inter-reader variability of diffusion weight imaging (DWI) interpretation(Up to 6 months)

研究点 (1)

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