Award Title: A MULTI-centre feasibility study to assess the use of 99m Tc-SestaMIBI SPECT/CT in the diagnosis of kidney tumours (MULTI-MIBI study).
Funder: Department of Health and Social Care

Abstract: 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.

Lay Abstract: Background to the research:   In the UK, over 13000 people are diagnosed with kidney tumours every year. Most are detected by chance on scans performed for other purposes. Standard treatment is surgical removal of the tumour together with part or the whole kidney, which carries serious risks and reduces overall kidney function. However, not all kidney tumours are cancers and up to 3 in 10 are benign (most are oncocytomas) which do not cause harm and do not need removal.    Currently, to tell if a tumour is benign or cancer requires having it surgically removed or having a biopsy. However, a biopsy is still an invasive procedure and most patients experience pain, and bruising, and must stop blood thinning tablets beforehand to reduce the risk of bleeding. Some patients and doctors also worry about  cancer spillage  from disrupting the tumour during a biopsy.    New studies from the USA, Sweden and China show that a type of nuclear medicine scan called  sestamibi  (MIBI) can distinguish cancer from benign kidney tumours. MIBI scans use very small doses of radio-active tracer and are safe, non-invasive and painless. They are currently used in the NHS for other indications, such as parathyroid and heart scans, and we have successfully performed a small study for patients with kidney tumours in our hospital.     Aim: This feasibility study will find out if MIBI scans can be used for patients with kidney tumours, and will also assess patient and clinician acceptability. The results will help design a larger multi-centre study to fully test the effectiveness of these scans in the NHS.      Design and methods used: This study will recruit 50 patients from 3-5 hospitals. We will invite people diagnosed with kidney tumours who are planned to have either a biopsy or surgery, to take part in this study and consent to have a MIBI scan. The MIBI scan will be compared to biopsy/surgery results. We will explore the perception, acceptability and experience of MIBI scans through patient and clinician interviews and surveys.     Patient and public involvement: We conducted an online pre-study survey of patients, carers and the public hosted by Kidney Cancer UK. Of 152 respondents, 89% would participate in the study. One of our patient representatives is a co-investigator, and has lived experience of kidney surgery for an oncocytoma. Both representatives have helped in drafting the study protocol and plain English summary, and will represent patient views on the trial management committee.     Dissemination: The results will be presented at national and international conferences, and published in peer reviewed medical journals. The patient community and carers will be informed of the results through patient education days hosted by KCUK and delivered via social media outlets to the broader public.

Research Activity Codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health Categories: CANCER AND NEOPLASMS