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

Обзор

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.

Вмешательства

• Устройство Hyperpolarised MRI
  Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.
• Устройство Sodium MRI
  MRI procedure as a regular MRI scan, the only change is us using a different sort of equipment so we are able to detect sodium.
• Устройство Deuterium metabolic imaging (DMI) MRI
  Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.

Первичные конечные точки

• LAC/PYR ratio [Срок оценки: 1 year]
• Total Sodium Concentration [Срок оценки: 1 year]
• Technical development of DMI in the abdomen [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Великобритания · 1 центр

• University Department of Radiology — Cambridge

Публикации

• Horvat-Menih I, McLean MA, Zamora-Morales MJ, Wylot M, Kaggie J, Khan AS, Gill AB, Duarte J, Locke MJ, Mendichovszky I, Li H, Priest AN, Warren AY, Welsh SJ, Jones JO, Armitage JN, Mitchell TJ, Stewart GD, Gallagher FA. Multiarm, non-randomised, single-centre feasibility study-investigation of the differential biology between benign and malignant renal masses using advanced magnetic resonance imag PMID 39461869

Идентификаторы

NCT: NCT06016075 · Radiology, Uni of Cambridge · 22/EE/0136 · 314155

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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