Multimodal Hypersprectal Imaging and Raman Spectroscopy for Intraoperative Assessment of Breast Tumor Resection Margins

Informations projet

Spectra- BREAST

N° de convention de subvention: 101187508

DOI

10.3030/101187508

Date de signature de la CE 29 Octobre 2024

Date de début 1 Decembre 2024

Date de fin 30 Novembre 2028

Financé au titre de

• The European Innovation Council (EIC)

Coût total

€ 2 990 207,50

Contribution de l’UE

€ 2 990 207,50

Coordonné par

ISTITUTI CLINICI SCIENTIFICI MAUGERI SOCIETA' PER AZIONI SOCIETA' BENEFIT
Italy

Periodic Reporting for period 1 - Spectra- BREAST (Multimodal Hypersprectal Imaging and Raman Spectroscopy for Intraoperative Assessment of Breast Tumor Resection Margins)

Période du rapport: 2024-12-01 au 2025-11-30

Résumé du contexte et des objectifs généraux du projet

Spectra-BREAST aims to revolutionize the assessment of tumor resection margins during breast conserving surgery (BCS). Currently, approximately 20% of breast cancer patients require a second operation due to incomplete removal of cancerous tissue. This results in increased costs for the healthcare system and significant negative effects on patients’ well-being. Nowadays, the standard margin assessment procedure is postoperative histopathological specimen analysis, which takes several days to complete. Although intraoperative histopathological analysis on frozen tissue is possible, it is less effective and cannot be implemented in all clinical centers. Alternative techniques have been suggested but have low diagnostic performance or take excessive time to assess the entire resected specimen. Spectra-BREAST aims to support surgeons with an intraoperative tool providing accurate and actionable feedback on the resection margin status over the whole specimen in less than 5 minutes. To this end, we will apply a radically new, high-risk multimodal approach combining two optical techniques, Hyperspectral Imaging (HSI) and fiber-optic Raman Spectroscopy (RS) with AI-based dataanalysis. Spectra-BREAST also has the potential for wider applications, going beyond breast cancer to include margin assessment for other cancers, robotic/laparoscopic surgery, and guided biopsy.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

During RP1, in accordance with the Grant Agreement, the consortium focused on the technical foundations of the work (development of the necessary optical components and an initial assessment of robotic assistance), on the set-up of the infrastructure needed to enable systematic data collection and subsequent integration/validation phases, and on the set-up of the clinical study necessary for the analysis of clinical specimens. In particular, in the technological work packages (WP1–WP4), activities concentrated on early development steps that prepare the HSI and Raman subsystems and the initial collection of data for the set-up of the AI pipeline for subsequent integration work (e.g. technical specifications, modelling/simulation, dataset preparation, and architecture planning). This work will initially lead to the delivery of the HSI imaging setup, the fiber-optic Raman system, and the pre-trained AI data analysis pipeline foreseen at M18. After that, RP2 will focus on the integration of the optical and robotic systems, the analysis of clinical samples, and the development of the AI algorithms. RP3 will be mostly related to the validation of the Spectra-BREAST device.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

SpectraBREAST ambitions to identify tumors on and below the resection surface (up to a depth of 2 mm), with an unprecedented high sensitivity and specificity (over 95%) in real-time.