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NCT07826858Recruiting

SPECTRA: Intraoperative Hyperspectral Imaging for Prostate Cancer

Source: ClinicalTrials.gov · Last updated 17 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
26 (estimated)
First submitted
31 Aug 2026
Start date
1 Aug 2026
Primary completion date
31 Aug 2027
Lead sponsor
Massimo Valerio
NCT number
NCT07826858

What you commit to

  • Study type: Interventional
  • Planned participants: 26
  • From 1 Aug 2026 to the primary completion date, 31 Aug 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Other

  • Unwilling to participate.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hôpitaux Universitaires de Genève - Dept de Chirurgie - Service d'Urologie
Coordinator of this site? Confirm its status
GenevaSwitzerlandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.