GigaFIBI; rapid, large-format histology-resolution imaging for Intraoperative assessment of breast lumpectomy margins

千兆FIBI；

• 批准号: 10568823
• 负责人: Farzad Fereidouni
• 金额: $ 64.65万
• 依托单位: UNIVERSITY OF CALIFORNIA AT DAVIS
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10568823
• 关键词: Adipose tissue; Anxiety; Appearance; Area; Attention; Breast; Breast Cancer Treatment; Breast Diseases; Breast-Conserving Surgery; Cancer Etiology; Carcinoma; Carcinoma in Situ; Caring; Clinical; Consumption; Cosmetics; Coupled; Diagnosis; Diagnostic; Diagnostic Imaging; Engineering; Evaluation; Excision; Feedback; Fellowship; Fluorescence; Fresh Tissue; Frozen Sections; Glass; Goals; Health Care Costs; Healthcare; Healthcare Systems; Histology; Histopathology; Image; Image Enhancement; Image-Guided Surgery; Imaging technology; In Situ; Left; Lighting; Magnetic Resonance Imaging; Malignant Neoplasms; Mammary Gland Parenchyma; Mammary Neoplasms; Mastectomy; Measures; Mechanics; Methodology; Methods; Microscopy; Molecular; Morbidity - disease rate; Operative Surgical Procedures; Optics; Outcome; Pathologist; Pathology; Patient-Focused Outcomes; Patients; Postoperative Period; Procedures; Process; Publishing; Qualifying; Radiation therapy; Reader; Recommendation; Recurrence; Recurrent Malignant Neoplasm; Recurrent tumor; Repeat Surgery; Reporting; Residual Neoplasm; Residual state; Resolution; Risk; Scanning; Sectioning technique; Sensitivity and Specificity; Series; Slide; Specificity; Specimen; Speed; Stains; Surface; Surgeon; Surgical margins; System; Techniques; Technology; Testing; Thinness; Time; Tissue imaging; Tissues; Training; United States; Woman; breast imaging; breast lumpectomy; breast surgery; cancer recurrence; clinical practice; contrast enhanced; cost; cost effective; diagnosis standard; diagnostic accuracy; diagnostic value; digital imaging; experience; feasibility testing; imaging approach; imaging system; improved; instrumentation; malignant breast neoplasm; microscopic imaging; novel; operation; preservation; psychosocial; recruit; safety and feasibility; standard care; standard of care; tissue processing; tool; tumor; validation studies

PROJECT SUMMARY Breast-conserving surgery (BCS), or lumpectomy, has become standard for the treatment of breast cancers. The goal of BCS is to remove the cancer and enough surrounding tissue to reduce the chance of tumor recurrence (clear margins) but retain as much of the normal breast appearance as possible. Although BCS has many advantages, residual tumor (positive margins) are found on post-operative pathology in 5–40% of cases, often necessitating an additional surgery and potential for treatment delays, increased healthcare costs, patient anxiety, and suboptimal cosmetic outcomes. Obtaining clear margins at the time of the initial breast surgery also has implications for malignancy, as margin status is the chief determinant of local recurrence. Therefore, technologies providing intraoperative margin assessment, in which real-time surgical guidance is most often coordinated with the pathology team, has the potential to substantially reduce the need for additional surgeries, improve patient outcomes, and increase health care value. Various methods have been proposed and evaluated for intraoperative breast margin assessment, including gross evaluation, frozen section analysis, optical and non-optical imaging, and others. While each of these techniques are suggested to reduce positive margin rates over non-guided surgeries, they also have inherent limitations (e.g. processing time, cost, permanent tissue changes), with varying degrees of sensitivity and specificity. Accordingly, a single intraoperative method has yet to be widely accepted into clinical practice and post-operative pathology remains the gold-standard for diagnosis and margin evaluation. The ideal tool for intraoperative BCS assessments would have a high degree of sensitivity to detect all tumor in the margins, regardless of tumor type, and, since diagnosis is not the intended outcome, specificity should be high enough to both limit false positives and the rate of return surgeries. To this end, we propose FIBI (Fluorescence Imitating Brightfield Imaging) for rapid, high-quality imaging of BCS tissues. We will use our already existing FIBI technology to engineer a novel system, Giga FIBI, capable of assessing large areas (up to 100 x 100 mm2) of fresh tissue, eliminating the need for substantial processing or sectioning. Through a series of validation studies, we will show that Giga FIBI generates microscopic images at a quality comparable to gold-standard histology from large surfaces within just minutes. Unlike other existing methodologies for imaging tissue directly without sectioning (slide-free techniques), Giga FIBI is a technically simple and cost- effective solution that is non-destructive, preserves orientation, and leaves the tissue available for downstream permanent histology or molecular tests. The practical guidance provided by Giga FIBI is expected to markedly enhance intraoperative breast tumor margin assessment to minimize repeat surgeries, local recurrence, and improve patient outcomes.

项目摘要 保乳手术（BCS），或乳房肿瘤切除术，已成为治疗乳腺癌的标准。 BCS的目标是切除癌症和足够的周围组织，以减少肿瘤的机会 复发（边缘清晰），但尽可能保留正常乳房外观。虽然BCS 许多优点，在5-40%的病例中，在术后病理学上发现了残留肿瘤（阳性边缘）， 这通常需要额外的手术，并可能导致治疗延迟、医疗费用增加、患者 焦虑和不理想的美容效果。在初次乳房手术时获得清晰的边缘 也暗示恶性肿瘤，因为切缘状态是局部复发的主要决定因素。因此，我们认为， 提供术中切缘评估的技术，其中最常见的是实时手术指导 与病理团队协调，有可能大大减少额外手术的需要， 改善患者的治疗效果，提高医疗保健价值。 已经提出并评价了各种方法用于术中乳腺切缘评估，包括 大体评估、冷冻切片分析、光学和非光学成像等。尽管每个 技术建议，以减少积极的边缘率超过非引导手术，他们也有固有的 局限性（例如处理时间、成本、永久性组织变化），具有不同程度的敏感性， 的特异性因此，单一的术中方法尚未被临床实践广泛接受， 术后病理仍然是诊断和边缘评估的金标准。 术中BCS评估的理想工具将具有高度的灵敏度，以检测所有 边缘肿瘤，无论肿瘤类型如何，由于诊断不是预期结果，特异性 应该足够高，以限制假阳性和返回手术率。为此，我们建议 用于BCS组织的快速、高质量成像的FIB（荧光仿射场成像）。我们将用我们 已经存在的FIB技术，设计一个新的系统，千兆FIB，能够评估大面积（上 至100 × 100 mm 2）的新鲜组织，从而消除了对大量处理或切片的需要。通过 一系列的验证研究，我们将表明，千兆FIB生成的显微图像的质量相当 几分钟内就能从大面积组织学上达到黄金标准。与其他现有方法不同， 直接成像组织而不切片（无载玻片技术），Giga FIB是一种技术简单、成本低的方法， 有效的解决方案，是非破坏性的，保持方向，并留下组织可用于下游 永久性组织学或分子测试。 Giga FIB提供的实用指导有望显着提高术中乳腺肿瘤 边缘评估，以尽量减少重复手术，局部复发和改善患者的结果。