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临床试验/NCT06016075
NCT06016075招募中不适用

Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques

University of Cambridge2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Total Sodium Concentration

研究概览

简要总结

The aim of this study is to develop techniques for non-invasive imaging of biology in participants with benign or malignant renal masses based on the novel scanning MRI techniques, including recently invented Hyperpolarised MRI, deuterium metabolic imaging and sodium MRI. This imaging study will: 1) acquire imaging data from human tissues following the injection of hyperpolarised 13C pyruvate and use 13C-MRI to monitor changes in the ratio of 13C-lactate to 13C-pyruvate; 2) acquire imaging data from human tissues using Sodium MRI or 3) acquire imaging data from human tissues following the oral consumable of deuterated glucose. Data acquired during this physiological study will be used to optimise future imaging protocols.In the UK and possibly in other countries, there are some patients with renal masses that are over treated or undergo unnecessary procedures such as surgery or biopsies, as they are thought to have a malignant tumour or a more aggressive tumour but after the procedure it is found that the mass was benign. The aim of this study is to determine whether one or all of these imaging techniques can differentiate between benign and malignant renal masses with the view to developing the techniques further and hopefully reducing the need for over treatment or unnecessary procedures in patients with benign masses.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • Over 18 years old
  • Able to and provide written informed consent to participate
  • If female, postmenopausal or if women of child bearing potential (WOCBP) using a suitable contraception
  • If male, using a suitable contraceptive method for the duration of the study
  • Radiologically suspected or pathologically confirmed benign or malignant renal masses, as determined by standard clinical practice
  • Capable of undergoing a minimum of one study visit

排除标准

  • Contraindication or inability to tolerate MRI
  • Pregnant or actively breast-feeding woman
  • If using an intrauterine contraceptive device (IUCD) as a method of contraception the device should be MRI safe at 3 T (researcher to confirm)
  • Clinically significant cardiac, pulmonary or neurological diseases as determined by the investigators
  • Laboratory abnormalities that may impact on the study results
  • Any other significant medical or psychiatric history rendering the subject ineligible as deemed by the investigators

结局指标

主要结局

Total Sodium Concentration

时间窗: 1 year

Total Sodium Concentration - in renal tumours

Technical development of DMI in the abdomen

时间窗: 1 year

Detection of metabolites within the DMI spectrum in the abdomen is limited by large lipid peaks and variability of tissues. Therefore, this work will aim to improve acquisition and processing methods to develop abdominal DMI with the hope to evaluate lactate across renal tumour subtypes.

LAC/PYR ratio

时间窗: 1 year

LAC/PYR ratio in renal tumours, which is a quantitative measure of conversion from pyruvate to lactate in the tissue of interest.

次要结局

未报告次要终点

研究者

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

Ines Horvat-Menih

Doctor

University of Cambridge

研究点 (2)

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