Protocol for a MULTI-centre feasibility study to assess the use of 99mTc-sestaMIBI SPECT/CT in the diagnosis of kidney tumours (MULTI-MIBI study).

The incidence of renal tumours is increasing and anatomic imaging cannot reliably distinguish benign tumours from renal cell carcinoma. Up to 30% of renal tumours are benign, with oncocytomas the most common type. Biopsy has not been routinely adopted in many centres due to concerns surrounding non-diagnostic rate, bleeding and tumour seeding. As a result, benign masses are often unnecessarily surgically resected. 99mTc-sestamibi SPECT/CT has shown high diagnostic accuracy for benign renal oncocytomas and other oncocytic renal neoplasms of low malignant potential in single-centre studies. The primary aim of MULTI-MIBI is to assess feasibility of a multicentre study of 99mTc-sestamibi SPECT/CT against a reference standard of histopathology from surgical resection or biopsy. Secondary aims of the study include obtaining estimates of 99mTc-sestamibi SPECT/CT sensitivity and specificity and to inform the design and conduct of a future definitive trial.

A feasibility prospective multicentre study of participants with indeterminate, clinical T1 renal tumours to undergo 99mTc-sestamibi SPECT/CT (index test) compared with histopathology from biopsy or surgical resection (reference test). Interpretation of the index and reference tests will be blinded to the results of the other. Recruitment rate as well as estimates of sensitivity, specificity, positive and negative predictive value will be reported. Semistructured interviews with patients and clinicians will provide qualitative data to inform onward trial design and delivery. Training materials for 99mTc-sestamibi SPECT/CT interpretation will be developed, assessed and optimised. Early health economic modelling using a decision analytic approach for different diagnostic strategies will be performed to understand the potential cost-effectiveness of 99mTc-sestamibi SPECT/CT.

Ethical approval has been granted (UK HRA REC 20/YH/0279) protocol V.5.0 dated 21/6/2022. Study outputs will be presented and published nationally and internationally.

ISRCTN12572202.

BMJ open. 2023 Jan 24*** epublish ***

Hannah Warren, Thomas Wagner, Michael A Gorin, Steven Rowe, Beverley Fiona Holman, Deborah Pencharz, Soha El-Sheikh, Ravi Barod, Prasad Patki, Faiz Mumtaz, Axel Bex, Veeru Kasivisvanathan, Caroline M Moore, Nicholas Campain, Jon Cartledge, Andrew Scarsbrook, Fahim Hassan, Tim S O'Brien, Grant D Stewart, Iosif Mendichovszky, Sabina Dizdarevic, Ammar Alanbuki, William H Wildgoose, Tze Wah, Cecilia Vindrola-Padros, Elena Pizzo, Hakim-Moulay Dehbi, Paula Lorgelly, Kurinchi Gurusamy, Mark Emberton, Maxine G B Tran

Division of Surgery and Interventional Science, University College London, London, UK ., Department of Nuclear Medicine, Royal Free Hospital, London, UK., Milton and Carroll Petrie Department of Urology, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Specialist Centre for Kidney Cancer, Royal Free Hospital, London, UK., Division of Surgery and Interventional Science, University College London, London, UK., Department of Urology, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK., Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK., Department of Radiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK., Department of Nuclear Medicine, Guy's and St Thomas' NHS Foundation Trust, London, UK., Department of Urology, Guy's and St Thomas' NHS Foundation Trust, London, UK., Department of Surgery, University of Cambridge, Cambridge, UK., Department of Radiology, University of Cambridge, Cambridge, UK., Department of Nuclear Medicine, University Hospitals Sussex NHS Foundation Trust, Worthing, UK., Department of Urology, University Hospitals Sussex NHS Foundation Trust, Worthing, UK., Patient Representative, London, UK., Rapid Research, Evaluation and Appraisal Lab (RREAL), Department of Targeted Intervention, University College London, London, UK., Department of Applied Health Research, University College London, London, UK., Institute of Clinical Trials and Methodology, University College London, London, UK.