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; 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.

抽象的 对大约一半的乳腺癌女性进行乳房切除术。乳房切除术后乳房 重建对身体形象，性，自尊和生活质量有好处。临床预后不良 乳房重建后通常涉及乳房切除术皮瓣坏死（MSFN）或其他并发症 与缺乏血液流动和对伤口组织体积的氧合有关。 MSFN和伤口裂开 导致许多挑战，包括伤口管理问题，延迟调整治疗，美学 妥协，植入物扩展，患者困扰和经济损失。一项允许外科医生的技术 围手术期评估和优化皮瓣的保存，同时避免并发症，对于确保 尽管已经探索了成功的临床结果。 有坏死风险的组织，由于每种技术都有一些挑战，因此没有人获得普遍接受 降低其临床实用性的问题。此外，没有单一技术既可以提供血液流动，又 氧合信息，这对于精确评估皮瓣生存力至关重要。我们最近的创新 近红外斑点对比弥散相关断层扫描（SCDCT）技术的开发提供了一种 无创（无染料）和非接触式均值用于血流分布的连续2D/3D成像 通过大/厚的组织体积，例如乳房切除术皮瓣。我们建议扩展此SCDCT 下一代多波长SCDCT（MW-SCDCT）设备的原型，以定期成像 乳房切除术皮瓣中的血流和氧合分布。新的高速算法2D映射 将开发3D图像重建以适应皮肤皮瓣的快速在线评估 血液动力学。该MW-SCDCT系统将使用标准组织模拟幻象进行测试/优化 （AIM 1）并针对基于商业染料的荧光血管造影装置（SPYELITE®）进行校准/验证 在猪（AIM 2）和患者（AIM 3）接受乳房切除术的患者（AIM 3）中 重建。体内研究将确定我们的MW-SCDCT在术中预测的能力 MSFN区域/量和术后优化增量扩展器量，以降低风险 MSFN和其他并发症。我们期望术前基线和 术中皮瓣流和氧合的术中改变将为皮瓣提供更准确的评估 可行性比一次性单参数测量（即血流，血液氧合或荧光 灌注）。研究成果将为设计MW-SCDCT指导性临床试验提供理由 乳房切除术和乳房重建，以降低术后并发症和医疗保健成本。而且， 这种无创（无染料），非接触，连续和成本效益的成像系统具有潜力 在许多其他临床环境中进行周期性使用，尤其是在可能无法进行接触测量的情况下， 例如，烧伤，伤口和其他类型的组织皮瓣的连续和纵向监测。