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

Study Overview
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Brief Summary
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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.

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

Conditions
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Kidney Cancer

Intervention / Treatment
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* Device: Hyperpolarised MRI
* Device: Sodium MRI
* Device: Deuterium metabolic imaging (DMI) MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hyperpolarised MRI<br>Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans. | Device: Hyperpolarised MRI<br>* Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.<br>|
| Other: Sodium MRI<br>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. | Device: Sodium MRI<br>* 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.<br>|
| Other: Deuterium metabolic imaging (DMI) MRI<br>Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans. | Device: Deuterium metabolic imaging (DMI) MRI<br>* Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 
| Total Sodium Concentration | Total Sodium Concentration - in renal tumours | 1 year | 
| 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. | 1 year |