SBIR Phase II: Novel size-changing, gadolinium-free contrast agent for magnetic resonance angiography

这一小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力将为血管成像提供工具，这是一个具有大量临床需求的医学领域。开发的血池造影剂(BPCA)具有颠覆当前磁共振血管成像(MRA)造影剂市场的潜力，因为与目前的基于Gd的造影剂(GBCA)相比，它改善了安全性并增强了血管系统的成像。所提出的技术有可能提高对比剂增强MRA的诊断和安全性。这为参与其中的每个人创造了一个双赢的局面。对于患有血管疾病的患者，该解决方案提供了一种更安全的替代方案，具有更准确的诊断，使医生能够开出更安全、更有效的治疗方法。对于患者的家人来说，由于及早发现疾病，它能够进行预防性治疗，从而减少了经济和社会负担。对于放射科医生来说，更清晰的MRA图像可能会带来更准确的诊断。该产品将销售给放射科医生和进行MRA以诊断血管血栓、肾狭窄和儿科MRA的医疗机构。这个小企业创新研究(SBIR)第二阶段项目旨在优化铁基BPCA，用于MRA检测血管疾病。对比剂增强MRA是血管成像的主要诊断程序。由于具有良好的对比度增强效果，目前市场上主要是基于Gd的造影剂(GBCA)；然而，由于其潜在的毒性，GBCA被设计为快速清除，只留下一个较短的MRA图像获取窗口，导致血管图像质量不佳。为了满足对能够提供增强血管成像的更安全造影剂的需求，第二阶段项目将优化一种铁基造影剂，该造影剂将能够延长成像窗口，以提高MRA分辨率，但通过肾脏过滤去除这种造影剂。研究目标包括：(1)优化最小可行产品，以减少剂量并提高安全性；(2)评估诊断成像效果和毒理学；(3)展示合成最终配方的放大制造工艺。该解决方案解决了降低商业化风险和使技术更接近市场所需的要点。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will provide a tool for vascular imaging, an area of medicine with a large clinical need. The developed blood pool contrast agent (BPCA) has the potential to disrupt the current magnetic resonance angiography (MRA) contrast agent market because of its improved safety profile and enhanced imaging of the vascular system compared to current gadolinium-based contrast agents (GBCAs). The proposed technology has the potential to improve the diagnosis and safety of contrast-enhanced MRA. This creates a win-win-win scenario for everyone involved. For patients with vascular disease, this solution provides a safer alternative with a more accurate diagnosis that will allow doctors to prescribe safer, more effective treatments. For the patient’s family, it reduces financial and social burdens by enabling preventive treatment due to earlier disease detection. For radiologists, the clearer MRA images may lead to more accurate diagnoses. The product will be marketed to radiologists and medical institutions that perform MRA to diagnose vascular thrombosis, renal stenosis, and pediatric MRA.This Small Business Innovation Research (SBIR) Phase II project seeks to optimize an iron-based BPCA for use in MRA for the detection of vascular diseases. Contrast-enhanced MRA is a staple diagnostic procedure for imaging blood vessels. The market is currently dominated by gadolinium-based contrast agents (GBCAs) due to their excellent contrast enhancing effects; however, due to their potential toxicity, GBCAs are designed to be rapidly cleared, leaving only a short window for MRA image acquisition and resulting in suboptimal image quality of blood vessels. To address the need for a safer contrast agent able to provide enhanced vascular imaging, the Phase II project will optimize an iron-based contrast agent that will enable an extended imaging window for improved MRA resolution, but which is removed by kidney filtration. The research objectives include: (1) optimizing the minimum viable product to enable dose reduction and enhance the safety profile; (2) evaluating diagnostic imaging efficacy and toxicology; and (3) demonstrating a scale-up manufacturing process for the synthesis of the final formulation. This solution addresses the major points required to de-risk commercialization and bring the technology closer to the market.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.