Investigation of the differential biology between benign and malignant renal masses using advanced magnetic resonance imaging techniques (IBM-Renal): a multi-arm, non-randomised feasibility study

Introduction Localised renal masses are an increasing burden on healthcare due to the rising number of cases. However, conventional imaging cannot reliably distinguish between benign and malignant renal masses, and renal mass biopsies are unable to characterise the entirety of the tumour due to sampling error, which may lead to delayed treatment or overtreatment. There is an unmet clinical need to develop novel imaging techniques to characterise renal masses more accurately. Renal tumours demonstrate characteristic metabolic reprogramming, and novel MRI methods have the potential to detect these metabolic perturbations which may therefore aid accurate characterisation. Here we present our study protocol for the Investigation of the differential biology of Benign and Malignant renal masses using advanced magnetic resonance imaging techniques (IBM-Renal). Methods and analysis IBM-Renal is a multi-arm, single-centre, non-randomised, feasibility study with the aim to provide preliminary evidence for the potential role of the novel MRI techniques to phenotype localised renal lesions. 30 patients with localised renal masses will be recruited to three imaging arms, with 10 patients in each: ([1][1]) hyperpolarised [1-13C]-pyruvate MRI (HP 13C-MRI), ([2][2]) deuterium metabolic imaging (DMI), and ([3][3]) sodium MRI (23Na-MRI). The diagnosis will be made on samples acquired at biopsy or at surgery. The primary objective is to investigate whether novel MRI techniques can identify the differences between benign and malignant tumours, while the secondary objectives aim to assess how complementary the techniques are, and if they provide additional information. Exploratory objective will be to link imaging findings with clinical data and molecular analyses for biological validation of the novel MRI techniques. Ethics and dissemination This study was ethically approved (UK REC HRA: 22/EE/0136; current protocol version 2.1 dated 11/08/2022). The plans for dissemination include presentations at conferences, publications in scientific journals, a doctoral thesis, and patient and public involvement. Registration details [ClinicalTrials.gov][4]: NCT06016075 Strengths and limitations of this study ### Competing Interest Statement GDS has received educational grants from Pfizer, AstraZeneca and Intuitive Surgical; consultancy fees from Pfizer, MSD, EUSA Pharma and CMR Surgical; Travel expenses from MSD and Pfizer; Speaker fees from Pfizer; Clinical lead (urology) National Kidney Cancer Audit and Topic Advisor for the NICE kidney cancer guideline. S.J.W. is a founder and director of Pinto Medical Consultancy. F.A.G. has research grants from GlaxoSmithKline and AstraZeneca, research support from GE Healthcare, and has consulted for AstraZeneca on behalf of the University of Cambridge. ### Clinical Trial NCT06016075 ### Funding Statement This research is funded by Cancer Research UK (EDDPMA-May22\100068, C19212/A27150), and is supported by the NIHR Cambridge Biomedical Centre (BRC 1215 20014), the Cancer Research UK Cambridge Centre. The views expressed are those of the authors and not necessarily those of the funders. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study with related documentation has been approved by the East of England - Cambridge East Research Ethics Committee (REC), Health Research Authority (HRA), receiving the REC reference: 22/EE/0136. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes No data was generated for this article. [1]: #ref-1 [2]: #ref-2 [3]: #ref-3 [4]: http://ClinicalTrials.gov