RecruitingNot ApplicableNCT07826858

SPECTRA: Intraoperative Hyperspectral Imaging for Prostate Cancer


Sponsor

Massimo Valerio

Enrollment

26 participants

Start Date

Aug 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Radical prostatectomy (RP) is currently one of the gold standard of care in managing localized prostate cancer (Pca). However, despite advances in Robot-Assisted RP (RARP), cancer cells may still be found (up to 42%) at the edge of the removed prostate specimen, commonly referred as Positive Surgical Margins (PSM). PSM are well-known risk factors of adverse oncological outcomes (biochemical recurrence). It is therefore essential to characterize intraoperatively the tumor extent. In RARP, the leading intraoperative margin assessment (IMA) technique, NeuroSAFE is based on Intra-operative frozen section (IFS) of both prostate lateral sides sampled at 3-5 mm intervals. However, despite proven oncological benefit, adoption is still limited to expert centers due to a prolonged operative time, loss of integrity of the surgical specimen for definitive histopathological analysis, omission of regions (apex, base), and logistical complexity (trained uropathologist, cryostat…). With this prospective single-center project, we wish to explore the use of non-invasive optical imaging technology, HyperSpectral Imaging (HSI), as a reliable alternative for examination of the ex-vivo prostate specimen to 1. Distinguish normal versus tumor tissue at the surgical margin in fresh specimen. 2. Quantify whether HSI can be integrated into the intraoperative workflow (feasibility), thus, image acquisition time and inference time should then be evaluated.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called HyperSpectral imaging acquisition of ex-vivo prostate specimen prior formalin fixation (fresh acquisition).. for people with hyperspectral imaging, localized prostate cancer, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHyperSpectral imaging acquisition of ex-vivo prostate specimen prior formalin fixation (fresh acquisition)..

The study specific specimen handling consists in a multi-Angle HSI Image Acquisition before routine pathology. To enhance the co-registration between the two modalities, a black-ink may be applied on the ex-vivo specimen based on a MRI suspicious region of extra-prostatic extension (EPE Grade ≥ 2). This procedure follows prior robust registration work between ex-vivo HSI and histology evaluation. The identification of this region will rely on the standard pre-operative MRI review already performed as part of routine care within our prostate cancer center before each radical prostatectomy.


Locations(1)

Hôpitaux Universitaires de Genève - Dept de Chirurgie - Service d'Urologie

Geneva, Canton of Geneva, Switzerland

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NCT07826858


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