N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Not applicable ClinicalTrials.gov

SPECTRA: Intraoperative Hyperspectral Imaging for Prostate Cancer

Sponsor: Massimo Valerio • ClinicalTrials.gov ID: NCT07826858

Registry updated: 2026-09-17
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

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

Eligibility criteria

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.

Conditions

Localized Prostate Cancer Positive Surgical Margin Hyperspectral Imaging

Locations

  • Hôpitaux Universitaires de Genève - Dept de Chirurgie - Service d'Urologie — Geneva, Canton of Geneva, Switzerland
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record