Multiarm, non-randomised, single-centre feasibility study-investigation of the differential biology between benign and malignant renal masses using advanced magnetic resonance imaging techniques (IBM-Renal): protocol

被引:0
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作者
Horvat-Menih, Ines [1 ]
McLean, Mary A. [1 ]
Zamora-Morales, Maria Jesus [1 ]
Wylot, Marta [1 ]
Kaggie, Joshua [1 ]
Khan, Alixander S. [1 ]
Gill, Andrew B. [1 ]
Duarte, Joao [1 ]
Locke, Matthew J. [1 ]
Mendichovszky, Iosif [1 ,2 ]
Li, Hao [1 ,3 ]
Priest, Andrew N. [4 ]
Warren, Anne Y. [5 ]
Welsh, Sarah J. [6 ]
Jones, James O. [6 ]
Armitage, James N. [7 ]
Mitchell, Thomas J. [7 ,8 ]
Stewart, Grant D. [7 ,8 ]
Gallagher, Ferdia A. [1 ]
机构
[1] Univ Cambridge, Dept Radiol, Cambridge, England
[2] Cambridge Univ Hosp NHS Fdn Trust, Dept Nucl Med, Cambridge, England
[3] Fudan Univ, Inst Sci & Technol Brain Inspired Intelligence, Shanghai, Peoples R China
[4] Cambridge Univ Hosp NHS Fdn Trust, Dept Radiol, Cambridge, England
[5] Cambridge Univ Hosp NHS Fdn Trust, Dept Pathol, Cambridge, England
[6] Cambridge Univ Hosp NHS Fdn Trust, Dept Oncol, Cambridge, England
[7] Cambridge Univ Hosp NHS Fdn Trust, Dept Urol, Cambridge, England
[8] Univ Cambridge, Dept Surg, Cambridge, England
来源
BMJ OPEN | 2024年 / 14卷 / 10期
关键词
Kidney tumours; Magnetic resonance imaging; Functional Magnetic Resonance Imaging; TOMOGRAPHY/COMPUTED TOMOGRAPHY; DIAGNOSTIC-ACCURACY; CANCER; ONCOCYTOMA; BIOPSY;
D O I
10.1136/bmjopen-2024-083980
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 MRI techniques (IBM-Renal).Methods and analysis IBM-Renal is a multiarm, 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) hyperpolarised [1-13C]-pyruvate MRI, (2) deuterium metabolic imaging (DMI) and (3) sodium MRI. The diagnosis will be made on samples acquired at biopsy or at surgery. The primary objective is the technical development of the novel MRI techniques, with the ultimate aim to understand whether these can identify differences between benign and malignant tumours, while the secondary objectives aim to assess how complementary the techniques are, and if they provide additional information. The exploratory objective is to link imaging findings with clinical data and molecular analyses for the 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 August 2022). The plans for dissemination include presentations at conferences, publications in scientific journals, a doctoral thesis and patient and public involvement.Trial registration number NCT06016075.NCT06016075
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