跳至主要内容
临床试验/NCT05937776
NCT05937776已完成不适用

Development of Activity MRI (aMRI): Direct Comparison to PET in Human Subjects

OHSU Knight Cancer Institute2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2023年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
Mean values of kᵢₒ*V of the entire tumor region

研究概览

简要总结

This is an observational study to compare the utility of the novel aMRI approach in human brain to the standard of care imaging approach for diagnosing and assessing glioma. Tumor cells have altered metabolism compared to normal cells.This makes metabolic activity imaging useful for diagnosing and assessing neurological disease. However, current options for metabolic activity imaging are limited. Metabolic activity imaging is primarily conducted using positron emission tomography (PET) with a radioactive tracer called fludeoxyglucose F-18 (¹⁸FDG). A PET scan is a procedure in which a small amount of radioactive glucose (¹⁸FDG) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. PET imaging is very expensive and is usually much less available than other imaging techniques such as magnetic resonance imaging (MRI). MRI uses radiofrequency waves and a strong magnetic field to provide clear and detailed pictures of internal organs and tissues. While MRI is more available than PET, it isn't as useful in evaluating metabolic activity. Unlike standard MRI, the aMRI approach uses new ways of analyzing MRI images that provides information about tumor cell metabolic activity. Via direct comparison with a standard metabolic imaging approach, ¹⁸FDG PET, this clinical trial will assess the validity of aMRI as a metabolic imaging approach for evaluating neurological disease in patients with glioma.

详细描述

PRIMARY OBJECTIVE:

I. Characterize how the metabolic aMRI parameter kᵢₒ*V differs in tumor versus (vs) normal brain. Researchers will assess the validity of aMRI as a metabolic imaging approach via direct comparison with a standard metabolic imaging approach, ¹⁸FDG PET.

SECONDARY OBJECTIVES:

I. Post-gadolinium (Gd) T1 MRI will be used to distinguish the contrast-enhancing "ring" region indicating the metabolically active tumor periphery from the less viable and/or necrotic tumor core. The utility of aMRI to differentially assess the metabolically active tumor periphery and necrotic core regions will be determined and compared to that of ¹⁸FDG PET (SUVmax).

II. Characterize how the metabolic aMRI parameter kᵢₒ*V differs in the various normal appearing brain sub-regions unaffected by tumor, in comparison to ¹⁸FDG PET.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (greater than 18 years of age) with glioma who require MRI and ¹⁸FDG-PET imaging.

排除标准

  • 未提供

结局指标

主要结局

Mean values of kᵢₒ*V of the entire tumor region

时间窗: Up to 1 year

In subjects with glioma brain tumors, outlines of tumor regions will be defined by post-contrast T1 magnetic resonance images. Mean values of kᵢₒ\*V of the entire tumor region will be obtained and in normal-appearing contralateral regions for comparison. The profile of mean values in these regions will be evaluated for efficacy in metabolically distinguishing them, and evaluated for correlation with the co-registered flurodeoxyglucose F-18 (¹⁸FDG) positron emission tomography (PET) (standardized uptake value maximum \[SUVmax\]) data. The observation of robust correlation with PET, would validate activity magnetic resonance imaging (aMRI) as a metabolic sensor.

次要结局

  • kᵢₒ*V in different normal appearing brain sub-regions, unaffected by tumor(Up to 1 year)
  • Mean value of kᵢₒ*V in the tumor periphery and core regions(Up to 1 year)

研究者

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

Martin Pike, Ph.D.

Principal Investigator

OHSU Knight Cancer Institute

研究点 (2)

Loading locations...

相似试验