About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Hyperpolarised MRI
DeviceHyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.
Sodium MRI
DeviceMRI procedure as a regular MRI scan, the only change is us using a different sort of equipment so we are able to detect sodium.
Deuterium metabolic imaging (DMI) MRI
DeviceDrink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.
Treatment groups
Trial outcomes
Primary outcomes
LAC/PYR ratio
LAC/PYR ratio in renal tumours, which is a quantitative measure of conversion from pyruvate to lactate in the tissue of interest.
Total Sodium Concentration
Total Sodium Concentration - in renal tumours
Technical development of DMI in the abdomen
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.
Sponsors and contacts
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