An interventional study of HyperSpectral imaging acquisition of ex-vivo prostate specimen prior formalin fixation (fresh acquisition).. in Localized Prostate Cancer, Positive Surgical Margin and Hyperspectral Imaging, sponsored by Massimo Valerio. Recruiting at 1 site in Switzerland. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Massimo Valerio · Not applicable, Interventional, and Diagnostic
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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
Prostate cancer (Pca) is the second most frequently diagnosed cancer in men worldwide with over 1.5 million new cases annually and a median age at diagnosis of 66 years. Despite the natural history being slow and clinically insignificant in most cases, its heterogeneity and high prevalence mean it remains the second leading cause of cancer-related death worldwide. Treatment options depend on cancer stage, risk stratification and patient preferences.
Radical prostatectomy (RP), which consists of the surgical removal of the prostate and the seminal vesicles, is one of the gold-standard curative treatment for localized diseases. RP techniques include open, laparoscopic, and robotic-assisted surgery. Despite recent advances in the robotic field, positive surgical margins (PSM) can occur up to 42 %. According to the International Society of Urological Pathology (ISUP), PSM is defined by tumor cells reaching the inked surgical margin of the prostatectomy specimen. PSM significantly reduces progression-free survival and is a known prognostic parameter for postoperative biochemical recurrence (BCR).
Current margin assessment relies on Intraoperative Frozen Section (IFS), the current gold-standard technique is the Neurovascular Structure-Adjacent Frozen-Section Examination (NeuroSAFE). It consists of an IFS analysis of tissue adjacent to neurovascular bundles. While this neurovascular structure sparing method improves postoperative erectile function and reduces PSM, its implementation is limited due to additional operating time (45-60 minutes), increased resource demands on pathology departments, and the inability to provide a whole specimen analysis.
Hyperspectral Imaging (HSI) combines conventional imaging (camera) with a spectrometer, providing both spatial and spectral information of the analyzed structures, enabling tissue differentiation based on structural properties. HSI uses reflectance spectroscopic imaging measurements, which involve a white light irradiation of the tissue and subsequently a recording of the remitted spectral intensities. The interaction between the incident light and the tissue modifies the light's spectral distribution with the reflected light containing information about the tissue composition. This technology has already been successfully applied in visceral surgery to quantify liver viability during ischemic and reperfusion phases. More recently, in Urology, HSI was successfully used as a predictive tool for early postoperative kidney graft.
Another clinical application of HSI is the ability to discriminate between normal and cancerous tissue as observed in gastric, head and neck (H\&N), colorectal, brain and breast cancers. Similarly, in 2024, spectral data from Diffuse Reflectance Spectroscopy (DRS) showed promising results achieving an average sensitivity of 89% with a specificity of 82%, in 59 prostatectomy specimens, confirming the potential of spectroscopy. However, DRS approach comes with limitations, more particularly in spatial orientation because it requires multiple point-based measurements across the prostate surface with the inability to evaluate the entire tissue volume. In contrast, HSI provides spatially resolved spectral data across the entire field of view, enabling comprehensive tissue mapping. In 2012, the feasibility of HSI for PCa detection was evaluated in in-vivo mice and in pathological tissue slides, achieving 93% sensitivity and 97% specificity using a support vector machine algorithm and providing an estimated AUC-ROC of 0.9485. In this context, HSI provides a unique opportunity to assess fully a specimen. However, its application for real-time margin assessment during surgery remains unexplored. Recently, a 3D pipeline that co-registers multi-angle ex-vivo HSI with volumetric histopathology was implemented, enabling voxel-wise tumor segmentation and AR visualization in H\&N specimens using convolutional neural networks (CNNs).
This project aims to validate HSI feasibility in ex-vivo prostate specimens. By providing a non-invasive and contactless evaluation in the operating theatre, HSI could reduce PSM rates, minimizing adjuvant radiotherapy needs and overall, improve long-term oncological outcomes.
In this research project, the TIVITA® Tissue system, a CMOS (Complementary Metal Oxide Semiconductor) Push-broom Scanning Hyperspectral Camera device, designed for real-time tissue assessment, will be employed. This CE (Conformité Européenne) certified device can provide 640x480 pixel images with a spectral range of 500 to 1000 nm and a spectral resolution of 5nm. The illumination system consists in six 20 W halogen spotlights (OSRAM GmbH, Munich, Germany). Each measurement takes approximately 7 seconds with a measured area up to 20-30 cm (wide enough for a whole prostate specimen).
93 studies on the registry are indexed under Margins of Excision; 37 are open to participants now.
This study's planned enrollment of 26 is below the median of 84 across 64 interventional studies indexed under Margins of Excision.
Browse Margins of Excision studies →Massimo Valerio is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: HyperSpectral 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.
Tumor extent
Dice similarity coefficient between HSI-derived and histopathology spatial overlap between the HSI tumor map and co-registered histopathology
Time frame: HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Boundary delineation
Normalized surface distance between HSI-derived andhistopathological tumor contours. Contour agreement
Time frame: HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Region overlap
Jaccard index between HSI-derived and histopathological tumor masks intersection over union
Time frame: HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Foreground discrimination
Pixel-wise sensitivity of HSI for tumor classification. Proportion of histologically tumor-positive pixels classified as tumor
Time frame: HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Background discrimination
Pixel-wise specificity of HSI for tumor classification . Proportion of histologically non-tumor pixels classified as non-tumor
Time frame: HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Overall agreement:
Pixel-wise accuracy of HSI for tumor classification. Proportion of evaluated pixels correctly classified, histopathology as reference
Time frame: HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Clinical workflow
HSI acquisition time
Time frame: HSI acquisition on Day 0 (day of surgery)
Computational runtime
Mean model inference time per hyperspectral image
Time frame: HSI acquisition on Day 0 (day of surgery)
Surgical margins
Diagnostic accuracy of HSI for detection of histologically positive margins
Time frame: HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Plan to share: No — Exploratory study with a small number of participants.
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Started Aug 2026 (actual). Primary completion is estimated for Aug 2027, 12 months after the start.
Of 28 interventional studies with no phase under Margins of Excision, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 63. This study's planned 12 months is below that.
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Massimo Valerio