Quantitative oxygen sensing to enable personalized oncology treatment planning

定量氧传感可实现个性化肿瘤治疗计划

• 批准号: 10325250
• 负责人: Gregory Ekchian
• 金额: $ 39.97万
• 依托单位: STRATAGEN BIO, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10325250
• 关键词: Address; Aftercare; Aging; Animal Model; Animals; Boston; Caliber; Cancer Patient; Catheters; Cervical; Clinical; Clinical Data; Clinical Trials; Common Neoplasm; Computer software; Custom; Data; Devices; Dimensions; Dose; Dose-Rate; Effectiveness; Ensure; Environment; Europe; Evaluation; Family suidae; Fiber Optics; Formulation; Generations; Gold; Grant; Head and Neck Cancer; Head and neck structure; Health; High-Dose Rate Brachytherapy; Hospitals; Human; Hypoxia; Image; Immunotherapy; Implant; Knowledge; Lead; Length; Limb structure; MRI Scans; Magnetic Resonance Imaging; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Malignant neoplasm of prostate; Manuals; Maps; Measurement; Measures; Medical; Methods; Modeling; Monitor; Oncology; Outcome; Output; Oxygen; Patient-Focused Outcomes; Patients; Performance; Phase; Polymers; Positioning Attribute; Process; Prostate; Radial; Radiation; Radiation Dose Unit; Radiation therapy; Radioactive; Resistance; Resolution; Seeds; Silicones; Solid Neoplasm; Sterilization; Surface; Survival Rate; Systemic Therapy; Techniques; Technology; Testing; Time; Tissue Viability; Tissues; Trauma; Treatment outcome; Tube; United States; United States Food and Drug Administration; Validation; Wireless Technology; Woman; Work; appropriate dose; biomaterial compatibility; chemotherapy; computerized data processing; design; effective therapy; human tissue; imaging modality; implantation; improved; in vivo; interest; interstitial; mechanical properties; meetings; outcome prediction; personalized medicine; porcine model; precision oncology; prevent; sensor; standard of care; therapy resistant; tissue phantom; treatment planning; trend; tumor; tumor hypoxia

Project Summary and Abstract Tumor oxygen levels are predictive of outcomes for patients receiving radiation therapy for cervical cancer. The effectiveness of radiation therapy is controlled by tumor oxygen with reduced effectiveness occurring in low oxygen regions. The survival rate for cervical cancer patients with a low oxygen tumor is 40% less than for patients with an oxygenated tumor. Resistance to therapy can be overcome by delivering an elevated dose of radiation. Existing oxygen sensing techniques cannot enable this treatment personalization because they are either impractically invasive or are indirect and qualitative. An appropriate dose escalation technique should enable localized delivery of elevated doses to only the low oxygen regions of a tumor. Interstitial high dose rate (HDR-brachy) is part of the current standard of care for many cervical cancer patients and involves the short- term placement (1 to 3 days) of plastic catheters (up to 30+, 2 mm diameter hollow tubes) throughout the tumor to serve as conduits for the temporary placement of radioactive seeds. Dose distribution is controlled by seed position and dwell time within the catheters which allows for hyper-localized and well-controlled dose escalation. The proposed oxygen sensor will address the unmet medical need for direct and quantitative measurements of tumor oxygen. This sensor leverages a proprietary oxygen sensing polymer, is made completely of silicone and is passive, wireless, and measured non-invasively using magnetic resonance imaging (MRI). This leverages the growing trend of using MRI during treatment planning and the catheter placement of HDR-brachy catheters. In the United States, MRI use has increased from 2% in 2007 to 34% in 2014, and it is the recommended imaging modality throughout Europe. The proposed device format is a new HDR-brachy catheter that includes the oxygen sensing polymer on the outside surface to achieve multiple discrete oxygen measurements along the length of the device, fast equilibration with tissue oxygen, and has a fully functional inner channel for radioactive seed placement. This will combine the ability to measure tissue oxygen levels and hyper-localize dose escalation. It will leverage the current standard of care to provide clinicians with actionable and easy to interpret oxygen measurements to personalize and improve clinical decisions. This sensor format is also readily translatable to other cancers treated with HDR-brachy and where patients suffer from treatment resistance and poor outcomes tied to low oxygen levels including prostate and head and neck cancers.

项目概要和摘要 肿瘤氧水平可预测接受宫颈癌放射治疗的患者的结局。的 放射治疗的有效性受肿瘤氧的控制， 氧气区域。低氧肿瘤的宫颈癌患者的存活率比低氧肿瘤的患者低40%。 患有含氧肿瘤的患者。对治疗的抗性可以通过递送增加剂量的 辐射现有的氧感测技术不能实现这种治疗个性化，因为它们是不可靠的。 要么是不切实际的侵入性，要么是间接的和定性的。适当的剂量递增技术应 能够将高剂量局部递送到肿瘤的低氧区域。间质高剂量率 （HDR-短）是目前许多宫颈癌患者护理标准的一部分，涉及短- 在整个肿瘤中长期放置（1至3天）塑料导管（最多30+，直径2 mm的中空管） 作为临时放置放射性粒子的管道。剂量分布由种子控制 位置和导管内的停留时间，这允许超局部化和良好控制的剂量递增。 所提出的氧传感器将解决未满足的直接和定量测量的医疗需求， 肿瘤氧。该传感器利用专有的氧传感聚合物，完全由硅胶制成， 是被动的、无线的，并且使用磁共振成像（MRI）进行非侵入性测量。这利用了 在治疗计划和HDR近距离导管的导管放置过程中使用MRI的趋势日益增长。在 在美国，MRI的使用从2007年的2%增加到2014年的34%，并且是推荐的成像方法。 整个欧洲的模式。申报器械格式是一种新的HDR-近距离导管，包括氧气 传感聚合物的外表面上，以实现沿沿着的长度的多个离散的氧测量， 该装置与组织氧快速平衡，并具有用于放射性种子的全功能内部通道 安置这将结合联合收割机测量组织氧水平和超局部剂量递增的能力。它 将利用当前的护理标准，为临床医生提供可操作且易于解释的氧气 测量，以个性化和改善临床决策。这种传感器格式也很容易转换为 使用HDR-近距离治疗的其他癌症，患者遭受治疗抵抗和不良结局 与低氧水平有关，包括前列腺癌和头颈癌。