[99mTc]Tc-sestamibi SPECT/CT (MIBI SPECT/CT) is a promising tool to differentiate benign and malignant renal tumours. We tested feasibility of recruitment to a prospective, multi-centre diagnostic test evaluation study of MIBI SPECT/CT for T1 renal tumours.
Consecutive adult patients with a newly-diagnosed clinical T1 (cT1) renal mass (2-7 cm) presenting to participating sites December 2022 - February 2024 were recruited and underwent MIBI SPECT/CT prior to histopathological diagnosis. Patients who accepted and declined participation and clinicians involved in study activities were invited to a semi-structured interview. The primary endpoint was feasibility of multi-centre recruitment. Secondary endpoints included qualitative assessment of barriers and facilitators to participation, estimates of MIBI SPECT/CT accuracy to detect cancer in order to power a definitive study, inter-rater agreement and identifying training needs for scan acquisition and interpretation.
Of 109 approached patients, 50 enrolled and underwent the study scan (45.8%, 95% CI 36.2-55.7%) across 6 sites. MIBI SPECT/CT scans were acquired and reported without the need for significant additional training. All scans were of adequate quality for interpretation. Sensitivity and specificity of MIBI SPECT/CT to detect cancer were 97.0% (95% CI 84.2-99.9%) and 53.8% (25.1-80.8%), respectively.
MULTI-MIBI has demonstrated feasibility of recruitment to a diagnostic evaluation study for T1 renal masses. Preliminary estimates of diagnostic accuracy suggest that MIBI SPECT/CT could reduce the number of patients with benign tumours undergoing surgery without missing a significant number of patients with malignant disease, however these results are limited by the small sample size in this feasibility study and a larger definitive study is needed prior to adoption in practice.
European journal of nuclear medicine and molecular imaging. 2025 Sep 23 [Epub ahead of print]
Hannah Warren, Thomas Wagner, Soha El-Sheikh, Nick Campain, Tze M Wah, Tim S O'Brien, Iosif A Mendichovszky, Sabina Dizdarevic, Charlie Stewart, Helen Ng, James Blackmur, Patrick Rogers, Andrew Scarsbrook, Dhruba Dasgupta, Fahim Ul-Hassan, Nitasha Singh, Ammar Alanbuki, Maryam Jessop, Linda Park, Kelly Leonard, Alex Wood, Ben Challacombe, Grant D Stewart, Ravi Barod, Prasad Patki, Faiz Mumtaz, Axel Bex, Veeru Kasivisvanathan, William Wildgoose, Sigrun Clark, Cecilia Vindrola-Padros, Elena Pizzo, Hakim-Moulay Dehbi, Mark Emberton, Maxine Gb Tran
Division of Surgery and Interventional Science, University College London, London, UK. ., Department of Nuclear Medicine, Royal Free Hospital, London, UK., Specialist Centre for Kidney Cancer, Department of Histopathology, Royal Free Hospital, London, UK., Department of Urology, Royal Devon University Hospitals NHS Foundation Trust, Exeter, UK., Department of Radiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK., Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK., Department of Nuclear Medicine, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK., Department of Nuclear Medicine, University Hospitals Sussex NHS Foundation Trust, Brighton, UK., Department of Urology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK., Department of Radiology, Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK., Department of Nuclear Medicine, Guy's & St Thomas' NHS Foundation Trust, London, UK., Department of Urology, University Hospitals Sussex NHS Foundation Trust, Brighton, UK., Department of Surgery, University of Cambridge, Cambridge Biomedical Campus, Cambridge, UK., Division of Surgery and Interventional Science, University College London, London, UK., Specialist Centre for Kidney Cancer, Urology Department, Royal Free Hospital, London, UK., Patient and Public representative, University College London, 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., Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, UCL, London, UK.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/40986089