[

BACKGROUND

With limitations of conventional imaging and biopsy, accurate, non-invasive techniques to detect clear-cell renal cell carcinoma in patients with renal masses remain an unmet need.

METHODS

ZIRCON was a prospective, open-label, multicentre, phase 3 trial conducted at 36 research hospitals and practices across nine countries (the USA, Australia, Canada, the UK, Türkiye, Belgium, the Netherlands, Spain, and France). Patients aged 18 years or older with an indeterminate renal mass 7 cm or smaller (cT1) suspicious for clear-cell renal cell carcinoma and scheduled for nephrectomy received a single dose of [

FINDINGS

Between Aug 14, 2019, and July 8, 2022, 371 patients were screened for eligibility, 332 of whom were enrolled. 300 patients received [

INTERPRETATION

Our results suggest that [

FUNDING

Telix Pharmaceuticals.

Informations de copyright

Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of interests BS has served as a consultant for Telix Pharmaceuticals, Veracyte, Merck, and Johnson & Johnson; has served as a speaker for Merck; and received travel support from Histosonics. AJP has received institutional funding and medical writing support from Telix Pharmaceuticals for this trial. J-CB has served as a consultant or advisor, and received honoraria and research funding from Bristol Myers Squibb, Conmed, Ipsen Pharmaceuticals, Merck Sharp and Dohme, Pfizer, and Intuitive Surgical. MAM has received institutional funding from Telix Pharmaceuticals; served as a board member for Oranomed, RayzeBio, Fusion, Advanced Molecular Imaging and Therapy, American College of Nuclear Medicine, and Society for Nuclear Medicine and Molecular Imaging; and holds stock or stock options from Advanced Molecular Imaging and Therapy, Gentem Health, and SoftThread. VM has received honoraria from Ethicon and Exelixis. AMS has received institutional research funding from Telix Pharmaceuticals, National Health and Medical Research Council, National Imaging Facility, National Breast Cancer Foundation, Medical Research Future Fund, Australian Cancer Research Foundation, and Victorian Cancer Agency; holds intellectual property licensing with Humanigen, AbbVie, and Life Science Pharmaceuticals; served as an advisory board member and consultant for ImmunOs and Imagion Bio; served as a board member, committee member, or chair for Fusion, Telix Pharmaceuticals, Australian and New Zealand Society of Nuclear Medicine, Australian and New Zealand Urogenital and Prostate Cancer trials group, Cooperative Trials Group for Neuro-Oncology, National Imaging Facility Molecular Imaging Theme, Australian Academy of Health and Medical Sciences, Melbourne Academic Centre for Health Molecular Imaging Theme, World Federation of Nuclear Medicine and Biology, Victorian Comprehensive Cancer Centre, Australian Nuclear Science and Technology Organisation External Advisory Board, and International Centers for Precision Oncology Foundation. CvP has served as consultant or advisor for Astellas and Merck; received honoraria from Astellas; and received travel funding from Ipsen. CBa has served as a data safety monitoring board or advisory board member for Telix Pharmaceuticals. BO has received research funding from Telix Pharmaceuticals. TA has received honoraria and research funding from Telix Pharmaceuticals. RM has received research funding from Telix Pharmaceuticals. DMS has received institutional research funding from Telix Pharmaceuticals; served as a consultant for Global Medical Solutions Taiwan, Progenics Pharmaceuticals, Heidelberg University, and DuChemBio; received payments or honoraria from the School of Breast Oncology, PrecisCa, and US Department of Justice; and served as an associate chair of Society for Nuclear Medicine and Molecular Imaging Scientific Program Committee. STL has received research funding from Telix Pharmaceuticals. NP-T has received honoraria from Actinium Pharmaceuticals; served as a consultant and advisor for Illumina, Imaginab, Actinium, and Progenics/Lantheus; a speaker for Actinium Pharmaceuticals and Telix Pharmaceuticals; and received institutional research funding from Actinium Pharmaceuticals, Imaginab, Regeneron Pharmaceuticals, Bristol Myers Squibb, Janssen, Clarity, Bayer Health, Telix Pharmaceuticals, and Ymabs. ACF is a board member of Molecular Decisions; a consultant or advisor for Verily; has received research funding from Earli, Filtricine, MagARRAY, and Calithera; and holds founders stock at Molecular Decisions, ACF's spouse is an employee or owner of Silverado Hospice and Antelope Valley Hospice. PA is an employee of Premier Research, and a consultant for Premier Research. KS is an employee of ABX-CRO advanced pharmaceutical services Forschungsgesellschaft. LT is an employee of Telix Pharmaceuticals and holds stock from Novartis. MW is an employee and holds patents and stock from Telix Pharmaceuticals. CBe is an employee of Telix Pharmaceuticals. CRWH was an employee of Telix Pharmaceuticals at the time of the trial. PM has received research funding from Telix Pharmaceuticals.