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临床试验/NCT05697406
NCT05697406招募中1 期

Hyperpolarized 13-C Pyruvate MRI Surveillance of Multiple Cancers

University of Maryland, Baltimore1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年6月24日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
招募中
入组人数
25
试验地点
1
主要终点
Pyruvate to Lactate Conversion

研究概览

简要总结

Many human diseases are characterized by their ability to alter existing metabolic pathways and interrupt cellular processes. Cancer exploits the Warburg effect and utilizes greater glucose than normal cells and within this process uses anaerobic respiration, leading to increased conversion of pyruvate to lactate. This can be exploited by hyperpolarized imaging. Hyperpolarized 13C MRI imaging is an approach that utilizes a stable isotope of Carbon (13C) linked to pyruvate. MRI spectroscopy is used in conjunction with hyperpolarized 13C pyruvate in order to temporally detect pyruvate and its conversion to lactate in-vivo, in order to visualize downstream metabolic (glycolytic) activity secondary to the Warburg effect, which should be useful in detecting and characterizing tumors of various types. Hyperpolarized 13C pyruvate MR imaging has not been tested in most cancers. In this preliminary survey, we will test the hypothesis that hyperpolarized 13C pyruvate MR imaging can be used to image various cancers.

详细描述

Most cancers exhibit the Warburg effect, which involves synthesis of lactate via glycolytic pathways. The present method of using 18F-FDG to image metabolic events only evaluates early glycolysis and does not investigate late glycolytic effects which can be examined by 13C pyruvate. The ability to detect cancer using 13C pyruvate has been shown using ovarian cancer models and in the prostate in humans, however its utility in other tumors needs clarification. Because cancers of various types affect metabolic pathways, it is necessary to improve imaging techniques to better investigate downstream metabolism. Many studies have shown that there are higher lactate levels in cancer tissue and higher levels of glycolysis. 13C pyruvate imaging takes advantage of these pathways by imaging the tumors while undergoing pyruvate to lactate conversion . From this modality, a three dimensional visualization of the tumor and metabolic products created by the pyruvate can be investigated.

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 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical tumor diagnosis
  • Patients with pre-existing MR imaging appointments
  • Must be able to undergo MR

排除标准

  • No tumor diagnosis

研究组 & 干预措施

Experimental

Experimental

Participants will receive an injection of 250 mM of hyperpolarized 13-C pyruvate intravenously after standard of care imaging sequences are performed. Then participants will undergo HP-MR imaging.

干预措施: Hyperpolarized 13C-Pyruvate (Drug)

结局指标

主要结局

Pyruvate to Lactate Conversion

时间窗: 18-36 months

Imaging Quality, KpL

次要结局

  • SNR(12-42 months)
  • CNR(12-42 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vikas Kundra

Chief of Oncologic Imaging

University of Maryland, Baltimore

研究点 (1)

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