A MULTI-centre feasibility study to assess the use of 99m Tc-SestaMIBI SPECT/CT in the diagnosis of kidney tumours (MULTI-MIBI study).

Research question: Is it feasible to recruit patients to a multi-centre study using 99TcSestamibi (MIBI) scans in the diagnosis of kidney tumours and what components are required for a full-scale multi-centre diagnostic accuracy study?

Background: Around 13000 people are diagnosed every year in the UK with a kidney tumour, and the incidence is increasing.

The standard of care is surgery, however, up to 30% of kidney tumours are benign, the majority of which are called oncocytomas which do not cause harm and do not need to be removed.

Conventional imaging such as CT or MRI cannot distinguish benign from cancerous tumours, and the only pre-surgical diagnostic tool is a tumour biopsy. However, biopsy is under-utilised due to concerns about pain, bleeding and tumour seeding of the biopsy track.

This means that a significant proportion of patients lose part or a whole kidney function, and find out afterwards that the tumour was benign and surgery was unnecessary.

Recent studies overseas have reported the use of a nuclear medicine scan (MIBI) to differentiate oncocytomas from kidney cancers. We have performed a small single centre study with 20 patients with high histopathology concordance of 95%.

Aims and objectives: The study aims to determine whether MIBI can be used in other centres (3-5 hospitals), assess patient and clinician acceptability, refine the inclusion/exclusion criteria, sample size requirements and determine clinician training needs for MIBI scan interpretation in the context of kidney tumours.

Methods: A feasibility study with three components: 1.

Multi-centre clinical trial to recruit patients with kidney tumours to have a MIBI scan prior to planned surgery of biopsy for diagnostic accuracy analysis. 2.

Mixed methods qualitative and quantitative study to assess patient and clinician perception and acceptability of MIBI, training needs of clinicians and determine minimally acceptable criteria for the definitive trial. 3.

Early health economic modelling using a decision analytic approach to explore the potential cost-effectiveness of MIBI in the NHS.

Timelines for delivery: The study is scheduled to take 24 months; 3 months for regulatory approvals, multi-site study set up and preparatory work, 15 months for recruitment, 3 months for completion of follow up data and 3 months for data analysis and future trial design and funding application.

Anticipated impact and dissemination: If MIBI is found to be an effective diagnostic tool in kidney tumours, then it will change clinical practice guidelines. National roll out and adoption will be rapid and facilitated as technology and equipment is already widely available.

This will reduce the number of unnecessary kidney surgeries, impacting on quality of life and outcomes for patients with benign kidney tumours as well as reducing surgical waiting list times for those with kidney cancer. There will also be impact on NHS resources, with likely cost savings.

Findings will be disseminated at national and international conferences, peer reviewed journals and patient websites such as Kidney Cancer UK, and hospital websites.

The study has support from the British Association of Urological Surgeons, Kidney Cancer UK and the British Society of Interventional Radiology.