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SPECTRA: Intraoperative Hyperspectral Imaging for Prostate Cancer (SPECTRA)

2026년 9월 14일 업데이트: Massimo Valerio

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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).

연구 유형

중재적

등록 (추정된)

26

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 스위스
    • Canton of Geneva
      • Geneva, Canton of Geneva, 스위스, 1205
        • 모병
        • Hôpitaux Universitaires de Genève - Dept de Chirurgie - Service d'Urologie
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Massimo Valerio, Prof Dr med
        • 부수사관:
          • Jean-Christophe Tille, MD
        • 부수사관:
          • Oliver Windisch, MD
        • 부수사관:
          • Michele Diana, Prof Dr med
        • 부수사관:
          • Doron Merkler, Prof Dr med
        • 부수사관:
          • Mario Kreutzfeldt, MD
        • 부수사관:
          • Andrew Janawczyk, Prof Dr med
        • 부수사관:
          • Vincent Benard, Resident
        • 부수사관:
          • Christian Lovis, Prof Dr med
        • 부수사관:
          • Mina Bjelogrlic, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 특수 증상
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Participants with prostate cancer undergoing robot-assisted prostatectomy. HyperSpectral imaging.

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.
절차: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Tumor extent
기간: HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Dice similarity coefficient between HSI-derived and histopathology spatial overlap between the HSI tumor map and co-registered histopathology
HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7

2차 결과 측정

결과 측정
측정값 설명
기간
Boundary delineation
기간: HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Normalized surface distance between HSI-derived andhistopathological tumor contours. Contour agreement
HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Region overlap
기간: HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Jaccard index between HSI-derived and histopathological tumor masks intersection over union
HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Foreground discrimination
기간: HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Pixel-wise sensitivity of HSI for tumor classification. Proportion of histologically tumor-positive pixels classified as tumor
HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Background discrimination
기간: HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Pixel-wise specificity of HSI for tumor classification . Proportion of histologically non-tumor pixels classified as non-tumor
HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Overall agreement:
기간: HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Pixel-wise accuracy of HSI for tumor classification. Proportion of evaluated pixels correctly classified, histopathology as reference
HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Clinical workflow
기간: HSI acquisition on Day 0 (day of surgery)
HSI acquisition time
HSI acquisition on Day 0 (day of surgery)
Computational runtime
기간: HSI acquisition on Day 0 (day of surgery)
Mean model inference time per hyperspectral image
HSI acquisition on Day 0 (day of surgery)

기타 결과 측정

결과 측정
측정값 설명
기간
Surgical margins
기간: HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7
Diagnostic accuracy of HSI for detection of histologically positive margins
HSI acquisition on Day 0 (day of surgery); reference histopathological assessment on postoperative Days 7

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Massimo Valerio

수사관

  • 수석 연구원: Massimo Valerio, HUG

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 8월 1일

기본 완료 (추정된)

2027년 8월 31일

연구 완료 (추정된)

2027년 12월 31일

연구 등록 날짜

최초 제출

2026년 8월 31일

QC 기준을 충족하는 최초 제출

2026년 9월 14일

처음 게시됨 (실제)

2026년 9월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 14일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2026-00595

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Exploratory study with a small number of participants.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다