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)

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

doi:10.1136/bmjopen-2022-067496

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)

BMJ Open. 2023 Jan 24;13(1):e067496. doi: 10.1136/bmjopen-2022-067496.

Authors

Hannah Warren^{1

2}, Thomas Wagner³, Michael A Gorin⁴, Steven Rowe^{5

6}, Beverley Fiona Holman³, Deborah Pencharz³, Soha El-Sheikh^{2

7}, Ravi Barod^{8

2}, Prasad Patki², Faiz Mumtaz^{8

2}, Axel Bex^{8

2}, Veeru Kasivisvanathan⁸, Caroline M Moore^{8

9}, Nicholas Campain¹⁰, Jon Cartledge¹¹, Andrew Scarsbrook¹², Fahim Hassan¹³, Tim S O'Brien¹⁴, Grant D Stewart¹⁵, Iosif Mendichovszky^{16

17}, Sabina Dizdarevic^{18

19}, Ammar Alanbuki²⁰, William H Wildgoose²¹, Tze Wah¹², Cecilia Vindrola-Padros²², Elena Pizzo²³, Hakim-Moulay Dehbi²⁴, Paula Lorgelly²³, Kurinchi Gurusamy⁸, Mark Emberton^{8

9}, Maxine G B Tran^{8

2}

Affiliations

¹ Division of Surgery and Interventional Science, University College London, London, UK [email protected].
² Specialist Centre for Kidney Cancer, Royal Free Hospital, London, UK.
³ Department of Nuclear Medicine, Royal Free Hospital, London, UK.
⁴ Milton and Carroll Petrie Department of Urology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
⁵ Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
⁶ Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
⁷ Department of Pathology, Royal Free Hospital, London, UK.
⁸ Division of Surgery and Interventional Science, University College London, London, UK.
⁹ Department of Urology, University College Hospital, London, UK.
¹⁰ Department of Urology, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.
¹¹ Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
¹² Department of Radiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
¹³ Department of Nuclear Medicine, Guy's and St Thomas' NHS Foundation Trust, London, UK.
¹⁴ Department of Urology, Guy's and St Thomas' NHS Foundation Trust, London, UK.
¹⁵ Department of Surgery, University of Cambridge, Cambridge, UK.
¹⁶ Department of Radiology, University of Cambridge, Cambridge, UK.
¹⁷ Department of Nuclear Medicine, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
¹⁸ Department of Nuclear Medicine, University Hospitals Sussex NHS Foundation Trust, Worthing, UK.
¹⁹ Brighton and Sussex Medical School, Brighton, UK.
²⁰ Department of Urology, University Hospitals Sussex NHS Foundation Trust, Worthing, UK.
²¹ Patient Representative, London, UK.
²² Rapid Research, Evaluation and Appraisal Lab (RREAL), Department of Targeted Intervention, University College London, London, UK.
²³ Department of Applied Health Research, University College London, London, UK.
²⁴ Institute of Clinical Trials and Methodology, University College London, London, UK.

Abstract

Introduction: 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.

Methods and analysis: 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.

Ethics and dissemination: 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.

Trial registration number: ISRCTN12572202.

Keywords: HEALTH ECONOMICS; Nuclear radiology; Urological tumours.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Feasibility Studies
Humans
Kidney Neoplasms* / diagnostic imaging
Multicenter Studies as Topic
Prospective Studies
Radiopharmaceuticals
Technetium Tc 99m Sestamibi
Tomography, Emission-Computed, Single-Photon*
Tomography, X-Ray Computed

Substances

Radiopharmaceuticals
Technetium Tc 99m Sestamibi

Grants and funding

C9685/A25177/CRUK_/Cancer Research UK/United Kingdom