Clinical trial · Interventional
SPECTRA: Intraoperative Hyperspectral Imaging for Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyperspectral Imaging | — | UNRESOLVED | — |
| Localized Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Positive Surgical Margin | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HyperSpectral imaging acquisition of ex-vivo prostate specimen prior formalin fixation (fresh acquisition).. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with prostate cancer undergoing robot-assisted prostatectomy. HyperSpectral imaging.
- description
- One visit related to the research protocol which consists in the information consultation during which the participant receives detailed oral and written information. RAPR (day 0) is performed according to standard practice and is not part of the research-specific procedure. The study is then based solely on ex-vivo analysis.
- interventionNames
- Procedure: HyperSpectral imaging acquisition of ex-vivo prostate specimen prior formalin fixation (fresh acquisition)..
Primary outcomes (1)
- measure
- Tumor extent
- timeFrame
- HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
- description
- Dice similarity coefficient between HSI-derived and histopathology spatial overlap between the HSI tumor map and co-registered histopathology
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available