Perioperative Diffuse Optical Imaging of Tissue Blood Flow and Oxygenation for Optimization of Mastectomy Skin Flap Viability

围手术期组织血流和氧合的漫射光学成像，用于优化乳房切除术皮瓣的活力

• 批准号: 10559475
• 负责人: Guoqiang Yu
• 金额: $ 49.04万
• 依托单位: UNIVERSITY OF KENTUCKY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-15 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10559475
• 关键词: Adjuvant Therapy; Algorithms; Area; Blood; Blood capillaries; Blood flow; Body Image; Brain; Brain Hypoxia-Ischemia; Breast; Burn injury; Calibration; Clinical; Clinical Trials; Color; Dermal; Development; Devices; Diagnosis; Diffuse; Distress; Dyes; Ensure; Esthetics; Excision; Family suidae; Fluorescence; Fluorescence Angiography; Health Care Costs; Hemorrhage; Heterogeneity; Human; Image; Imaging Techniques; Implant; Incidence; Indocyanine Green; Interruption; Judgment; Laboratories; Lateral; Mammaplasty; Maps; Mastectomy; Measurement; Measures; Metabolic; Monitor; Necrosis; Operative Surgical Procedures; Optics; Outcome; Outcome Study; Oxygen; Patients; Pattern; Perfusion; Perioperative; Postoperative Complications; Postoperative Period; Quality of life; Risk; Risk Reduction; Rodent; Sexuality; Skin; Speed; Surface; Surgeon; System; Techniques; Technology; Temperature; Testing; Thick; Three-Dimensional Image; Three-Dimensional Imaging; Tissue imaging; Tissues; Woman; breast surgery; clinical prognosis; cost efficient; design; diffuse optical spectroscopy and imaging; hemodynamics; image reconstruction; imager; imaging system; in vivo; innovation; malignant breast neoplasm; multimodality; next generation; non-invasive optical imaging; novel; operation; preclinical study; preservation; prevent; prototype; self esteem; surgery outcome; tomography; translational study; wound; wound treatment

ABSTRACT Mastectomy is performed on approximately half of women with breast cancer. Postmastectomy breast reconstruction has benefits for body image, sexuality, self-esteem, and quality of life. Poor clinical prognoses after breast reconstruction often involve mastectomy skin flap necrosis (MSFN) or other complications associated with the lack of blood flow and oxygenation to wound tissue volumes. MSFN and wound dehiscence leads to a number of challenges, including wound management problems, delays to adjuvant therapy, esthetic compromise, implant extrusion, patient distress, and financial loss. A technology that allows surgeons to perioperatively assess and optimize preservation of skin flaps while avoiding complications is essential to ensure successful clinical outcomes. Although alternative techniques have been explored to identify ischemic-hypoxic tissues at risk of necrosis, none have achieved universal acceptance as each technique has a few challenging issues that decrease its clinical usefulness. Moreover, no single technique provides both blood flow and oxygenation information, which are essential for precise assessment of skin flap viability. Our recent innovative development of near-infrared speckle contrast diffuse correlation tomography (scDCT) technique provides a noninvasive (dye-free) and noncontact means for continuous 2D/3D imaging of blood flow distributions throughout large/thick tissue volumes such as mastectomy skin flaps. We propose to extend this scDCT prototype to a next generation multi-wavelength scDCT (MW-scDCT) device for perioperative imaging of both blood flow and oxygenation distributions in mastectomy skin flaps. New high-speed algorithms for 2D mapping and 3D image reconstruction will be developed to accommodate rapid online assessment of skin flap hemodynamics. This MW-scDCT system will be tested/optimized using standard tissue-simulating phantoms (Aim 1) and calibrated/validated against a commercial dye-based fluorescence angiography device (SPY Elite®) in swine (Aim 2) and patients (Aim 3) undergoing mastectomy with expander-implant based breast reconstruction. The in vivo studies will determine the capability of our MW-scDCT for intraoperative prediction of MSFN regions/volumes and postoperative optimization of incremental expander volumes to reduce risks of MSFN and other complications. We expect that combined measurements of preoperative baseline and intraoperative alteration in skin flap flow and oxygenation will provide a more accurate assessment of skin flap viability than a one-time single-parameter measurement (i.e., blood flow, blood oxygenation, or fluorescence perfusion). Study outcomes will provide the rationale for designing MW-scDCT guided clinical trials of mastectomy with breast reconstruction to reduce postoperative complications and healthcare costs. Moreover, this noninvasive (dye-free), noncontact, continuous, and cost-efficient imaging system has the potential for perioperative use in many other clinical settings, especially where contact measurements may not be possible, such as for continual and longitudinal monitoring of burns, wounds, and other types of tissue flaps.

摘要 大约一半的乳腺癌妇女接受乳房切除术。乳房切除术后乳房 重建对身体形象、性、自尊和生活质量都有好处。临床表现不佳 乳房再造术后常涉及乳房切除术后皮瓣坏死（MSFN）或其他并发症 这与伤口组织体积缺乏血流和氧合有关。MSFN和伤口裂开 导致了许多挑战，包括伤口处理问题、辅助治疗的延迟、美学问题、 妥协、植入物挤出、患者痛苦和经济损失。这项技术可以让外科医生 围手术期评估和优化皮瓣的保存，同时避免并发症是至关重要的，以确保 成功的临床结果。尽管已经探索了替代技术来识别缺血缺氧性 组织坏死的风险，没有一种技术获得普遍接受，因为每种技术都有一些挑战性， 降低其临床实用性的问题。此外，没有一种技术同时提供血流和 氧合信息，这是必要的精确评估皮瓣的活力。我们最近的创新 近红外散斑衬度扩散相关断层成像（scDCT）技术的发展提供了一种 用于血流分布的连续2D/3D成像的非侵入性（无染料）和非接触装置 贯穿大/厚的组织体积，例如乳房切除术皮瓣。我们建议扩展这个scDCT 下一代多波长scDCT（MW-scDCT）设备的原型，用于 乳腺切除皮瓣的血流和氧合分布。新的高速二维映射算法 并将开发三维图像重建，以适应皮瓣的快速在线评估 血流动力学该MW-scDCT系统将使用标准组织模拟体模进行测试/优化 (Aim 1）并根据商业染料荧光血管造影设备（SPY Elite®）进行校准/验证 在猪（目标2）和患者（目标3）中进行乳房切除术，使用基于扩张器植入体的乳房 重建体内研究将确定我们的MW-scDCT用于术中预测的能力， MSFN区域/体积和增量扩张器体积的术后优化，以降低 MSFN和其他并发症。我们希望术前基线和术后随访的综合测量结果 术中皮瓣血流和氧合变化将提供更准确的皮瓣评估 比一次性单参数测量更有效（即，血流、血氧或荧光 灌注）。研究结果将为设计MW-scDCT指导的临床试验提供依据， 乳房切除术和乳房重建，以减少术后并发症和医疗费用。此外，委员会认为， 这种非侵入性（无染料）、非接触、连续和成本有效的成像系统具有以下潜力： 在许多其他临床环境中的围手术期使用，特别是在接触式测量可能不可能的情况下， 例如用于对烧伤、伤口和其他类型的组织瓣进行连续和纵向监测。