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Cambridge kidney One-Stop Mass Investigation Clinic (CkOSMIC): A Non-randomised Feasibility Study

Munich / Cambridge, March 10, 2026 – In this publication, the authors report the description of the initial experience with a one-stop renal mass biopsy (RMB) clinic in which the VivaScope® 2500 is used as part of a novel pathway.

The diagnosis of a radiologically indeterminate renal mass relies on imaging-guided biopsy. Confirming the histological diagnosis is particularly important in choosing the most appropriate systemic treatment. The rising incidence of incidental small renal masses has increased the need for percutaneous RMB. This has led to challenges in time-constrained diagnosis and treatment. A proposed strategy to expedite cancer diagnosis is the development of one-stop clinics. The concept of a ‘‘one-stop’’ service involves collaboration among multiple health care professionals to assess patients on a same-day basis. Typically, a patient attends the one-stop clinic and has investigations and a diagnosis within the same day. However, owing to the time needed for specimen preparation and assessment, pathological diagnosis has not been widely adopted within a one-stop clinic paradigm. Against this background, they established the first one-stop biopsy clinic for patients with suspected renal cancer referred for RMB with rapid pathological assessment via VivaScope® 2500 confocal microscopy.

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In this study, the innovative VivaScope® 2500 technology allowed rapid examination of fresh US-guided kidney biopsy conducted in 50 patients, of whom 48 received a provisional diagnosis immediately. The sensitivity and specificity for identification of malignancy were 94% and 100%, respectively. There was complete agreement between confocal and final pathology for 91.7% (n = 44) of the patients, and partial concordance (cancer identified but equivocal histological subtype) for 8.3% (n = 4). Time from first consultation to a treatment decision, and time from biopsy to treatment decision were significantly shorter in the CkOSMIC pathway (25 days) than in the standard pathway (55 days). Time from biopsy to treatment decision was also significantly shorter in the CkOSMIC pathway (0 day) than in the standard pathway (24 days). Four cases required repeat biopsy as no lesional tissue was seen on confocal microscopy; these were performed on the same day and the significant delay that otherwise occurred by standard histopathological assessment and later scheduling of a repeat biopsy, was avoided. There were no cases for which VivaScope technology incorrectly indicated that a lesion was benign or malignant. Notably, all final pathology results at surgery were concordant with the corresponding biopsy findings.

The novel pathway offers the following advantages:
• Enable biopsy results within minutes
• High sensitivity and specificity in diagnosing renal cancer
• Required repeat biopsy performed immediately allowing same-day diagnosis
• Diagnosis and treatment plan on 1 day
• Reduces hospital visits and potentially reduces anxiety of delays in forming a treatment plan

This one-stop clinic model in which the VivaScope® 2500 images are used for diagnosis and to define the treatment plan could become the standard pathway for Renal Mass Biopsy. This one-stop clinic model where diagnosis and treatment plan are provided on 1 day could be applied to the diagnosis of other pathologies, like breast or other urological cancers, relieving patient anxiety and improving patient prognosis.