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NCT07826858Recruiting

SPECTRA: Intraoperative Hyperspectral Imaging for Prostate Cancer

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.

Inclusion criteria

• Histological diagnosis (biopsy) of Pca • Prostate volume \< 100 cm3 (measured on preoperative MRI) for a smooth acquisition with the hyperspectral device • Capable of forming his own views

Exclusion criteria

• Unwilling to participate. • Inability to follow study procedures, for example due to language problems, psychological disorders, dementia, etc.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
No phase (N/A)
Study type
Interventional
Countries
Switzerland
Sponsor
Massimo Valerio(Other)
Protocol no.
2026-00595
Conditions
Localized Prostate Cancer, Positive Surgical Margin, Hyperspectral Imaging
Interventions
Procedure

Treatments studied

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

Locations · 1

  • Geneva, SwitzerlandHôpitaux Universitaires de Genève - Dept de Chirurgie - Service d'UrologieRecruiting at this site

In total, worldwide, the only site listed in the registry is recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: September 17, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.