. 2023 Jan 24;13(1):e067496.

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)

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 h.warren@ucl.ac.uk.
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.

PMID: 36693694
PMCID: PMC9884914
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)

Hannah Warren et al. BMJ Open. 2023.

. 2023 Jan 24;13(1):e067496.

doi: 10.1136/bmjopen-2022-067496.

Authors

Affiliations

¹ Division of Surgery and Interventional Science, University College London, London, UK h.warren@ucl.ac.uk.
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.

PMID: 36693694
PMCID: PMC9884914
DOI: 10.1136/bmjopen-2022-067496

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.

PubMed Disclaimer

Conflict of interest statement

Competing interests: GDS has received educational grants from Pfizer, AstraZeneca and Intuitive Surgical; consultancy fees from Pfizer, Merck, EUSA Pharma and CMR Surgical; Travel expenses from Pfizer and Speaker fees from Pfizer. SD provides educational consultancy for GE Healthcare, Bayer, AAA and AVAANT diagnostics.

Figures

See this image and copyright information in PMC

Cited by

Diagnostic Biopsy for Small Renal Tumours: A Survey of Current European Practice.
Warren H, Rautio A, Marandino L, Pyrgidis N, Tzelves L, Roussel E, Muselaers S, Erdem S, Palumbo C, Amparore D, Wu Z, Ciccarese C, Diana P, Borregales L, Pavan N, Pecoraro A, Caliò A, Klatte T, Carbonara U, Marchioni M, Bertolo R, Campi R, Tran MGB. Warren H, et al. Eur Urol Open Sci. 2024 Mar 2;62:54-60. doi: 10.1016/j.euros.2024.02.002. eCollection 2024 Apr. Eur Urol Open Sci. 2024. PMID: 38585205 Free PMC article.
^99mTc-sestamibi SPECT/CT-the jury is still out!
Warren H, Tran MGB. Warren H, et al. Transl Androl Urol. 2024 Jun 30;13(6):1053-1055. doi: 10.21037/tau-23-623. Epub 2024 May 13. Transl Androl Urol. 2024. PMID: 38983466 Free PMC article. No abstract available.
Machine Learning Integrating ^99mTc Sestamibi SPECT/CT and Radiomics Data Achieves Optimal Characterization of Renal Oncocytic Tumors.
Klontzas ME, Koltsakis E, Kalarakis G, Trpkov K, Papathomas T, Karantanas AH, Tzortzakakis A. Klontzas ME, et al. Cancers (Basel). 2023 Jul 9;15(14):3553. doi: 10.3390/cancers15143553. Cancers (Basel). 2023. PMID: 37509214 Free PMC article.
Imaging modalities for characterising T1 renal tumours: A systematic review and meta-analysis of diagnostic accuracy.
Warren H, Fanshawe JB, Mok V, Iyer P, Chan VW, Hesketh R, Zimmermann E, Kasivisvanathan V, Emberton M, Tran MGB, Gurusamy K. Warren H, et al. BJUI Compass. 2024 Jun 21;5(7):636-650. doi: 10.1002/bco2.355. eCollection 2024 Jul. BJUI Compass. 2024. PMID: 39022655 Free PMC article. Review.

References

1. Nayan M, Jewett MAS, Finelli A. Uncoupling diagnosis and treatment of incidentally imaged renal masses. JAMA Intern Med 2018;178:727–8. 10.1001/jamainternmed.2018.1180 - DOI - PubMed
1. Kim JH, Li S, Khandwala Y, et al. . Association of prevalence of benign pathologic findings after partial nephrectomy with preoperative imaging patterns in the United States from 2007 to 2014. JAMA Surg 2019;154:225–31. 10.1001/jamasurg.2018.4602 - DOI - PMC - PubMed
1. Fernando A, Fowler S, O'Brien T, et al. . Nephron-sparing surgery across a nation - outcomes from the British Association of Urological Surgeons 2012 national partial nephrectomy audit. BJU Int 2016;117:874–82. 10.1111/bju.13353 - DOI - PubMed
1. Neves J, Varley R, Agnesi S, et al. . Growth and renal function dynamics of renal oncocytomas on active surveillance: a retrospective cohort analysis. BJU International 2021;128:722–7. 10.1111/bju.15499 - DOI - PubMed
1. Liu S, Lee S, Rashid P, et al. . Active surveillance is suitable for intermediate term follow-up of renal oncocytoma diagnosed by percutaneous core biopsy. BJU Int 2016;118 Suppl 3:30–4. 10.1111/bju.13538 - DOI - PubMed

Publication types

Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions
Actions

Grants and funding

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

LinkOut - more resources

Full Text Sources
Medical
- MedlinePlus Health Information
Research Materials
- NCI CPTC Antibody Characterization Program

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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)

Affiliations

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)

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Research Materials

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

Substances

Related information

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Research Materials