Intraoperative Margin Assessment in Breast Cancer With HSI-Raman

Официальное название

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

Обзор

Breast-conserving surgery (lumpectomy) aims to remove cancer while preserving healthy tissue, but up to 20% of patients require a second operation because cancer cells remain at the edge (margin) of the removed tissue. The Spectra-BREAST study evaluates a new optical device that combines hyperspectral imaging (HIS) and Raman spectroscopy (RS) with artificial-intelligence analysis to quickly assess the entire surface of excised breast specimens during surgery. By flagging areas at risk of positive margins in real time, the device may help surgeons remove any remaining cancer in a single procedure. In this prospective, single-arm diagnostic study, surgeons will use the Spectra-BREAST system on freshly resected breast tissue from up to 99 women undergoing lumpectomy for invasive carcinoma or ductal carcinoma in situ. First, the device's cancer-detection algorithms will be trained on 74 specimens with known pathology. Then, in a separate group of patients, the fully integrated device will be tested on all six faces of each lumpectomy specimen and its predictions will be compared against the gold-standard histopathology margin assessment. Key measures include the sensitivity and specificity of the device's margin predictions, the time needed to generate results, and the device's usability in a clinical setting.

Вмешательства

• Диагностический тест Spectra-BREAST system in Invasive Breast Cancer
  Participants' excised breast lumpectomy specimens will be immediately imaged ex vivo using the investigational Spectra-BREAST system, a handheld optical device integrating two modalities Hyperspectral imaging (HSI): HSI captures reflectance spectra across 400-1400 nm over the entire specimen surface (up to 5 × 5 cm field of view). HIS provides spatial maps of tissue chemical composition and morphology to highlight regions suspicious for residual carcinoma. Point-wise Raman spectroscopy (RS):
• Диагностический тест Spectra-BREAST system in DCIS Breast Cancer
  Participants' excised breast lumpectomy specimens will be immediately imaged ex vivo using the investigational Spectra-BREAST system, a handheld optical device integrating two modalities Hyperspectral imaging (HSI): HSI captures reflectance spectra across 400-1400 nm over the entire specimen surface (up to 5 × 5 cm field of view). HIS provides spatial maps of tissue chemical composition and morphology to highlight regions suspicious for residual carcinoma. Point-wise Raman spectroscopy (RS): RS

Первичные конечные точки

• Sensitivity and specificity of Spectra-BREAST system margin status prediction [Срок оценки: Within 21 days after surgery (latest expected receipt of the final pathology report).]

Вторичные конечные точки (2)

• Concordance of HSI-only versus combined HSI + RS predictions [Срок оценки: During Spectra-BREAST procedure]
• Time from specimen removal to Spectra-BREAST system result [Срок оценки: Per specimen, measured intraoperatively]

Критерии участия

Критерии включения

Histologically confirmed diagnosis of ductal carcinoma in situ (B5a) or invasive breast carcinoma (B5b) on pre-operative core needle biopsy

Scheduled to undergo breast-conserving surgery (lumpectomy)

Able and willing to provide written informed consent

Критерии исключения

Pre-operative histologic or cytologic diagnosis of a benign breast lesion (B2/C2)

Initial diagnosis of advanced (stage III/IV) or metastatic breast carcinoma, or indication for neoadjuvant chemotherapy

Neurocognitive disorders that would impair comprehension of the study procedures or consent process

Concurrent pregnancy or breastfeeding

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• Istituti Clinici Scientifici Maugeri IRCCS — Pavia

Идентификаторы

NCT: NCT07111728 · 0012251/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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