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 肿瘤氧水平可以预测接受宫颈癌放射治疗的患者的结果。这 放射治疗的有效性由肿瘤氧控制，低浓度时有效性降低 氧气区域。患有低氧肿瘤的宫颈癌患者的生存率比患有低氧肿瘤的宫颈癌患者低40% 患有氧合肿瘤的患者。可以通过增加剂量来克服对治疗的抵抗力 辐射。现有的氧传感技术无法实现这种个性化治疗，因为它们 要么是不切实际的侵入性的，要么是间接的和定性的。适当的剂量递增技术应该 能够将升高的剂量局部输送到肿瘤的低氧区域。间质高剂量率 （HDR-brachy）是许多宫颈癌患者当前护理标准的一部分，涉及短期治疗 在整个肿瘤中定期放置塑料导管（最多 30 个以上、直径 2 毫米的空心管）（1 至 3 天） 作为临时放置放射性种子的管道。剂量分布由种子控制 导管内的位置和停留时间允许超局部化和良好控制的剂量递增。 拟议的氧气传感器将解决直接和定量测量未满足的医疗需求 肿瘤氧气。该传感器采用专有的氧传感聚合物，完全由硅树脂制成，并且 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 短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的使用率从2007年的2%增加到2014年的34%，是推荐的影像学检查 整个欧洲的模式。拟议的设备形式是一种新的 HDR 短距离导管，其中包括氧气 外表面的传感聚合物可沿其长度实现多个离散的氧气测量 该装置与组织氧快速平衡，并具有功能齐全的放射性种子内部通道 放置。这将结合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 测量以个性化和改进临床决策。这种传感器格式也很容易转换为 其他接受 HDR-brachy 治疗且患者出现治疗耐药和预后不良的癌症 与低氧水平有关，包括前列腺癌和头颈癌。