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

这个小型企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力将为血管成像提供一种工具，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）有可能破坏目前的磁共振血管造影（MRA）造影剂市场，因为与目前的钆基造影剂（GBCA）相比，其安全性得到改善，血管系统的成像得到增强。所提出的技术有可能提高对比增强MRA的诊断和安全性。这为所有参与者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，更有效的治疗方案。对于患者家庭来说，由于早期发现疾病，因此能够进行预防性治疗，从而减轻了经济和社会负担。对于放射科医生来说，更清晰的MRA图像可能会导致更准确的诊断。该产品将销售给放射科医生和医疗机构进行MRA诊断血管血栓形成，肾狭窄，儿科MRA。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。对比增强MRA是血管成像的主要诊断程序。 目前市场主要由钆基造影剂（GBCA）主导，因为它们具有出色的对比度增强效果;然而，由于其潜在的毒性，GBCA被设计为快速清除，仅为MRA图像采集留下很短的窗口，并导致血管的图像质量不佳。为了满足对能够提供增强血管成像的更安全的造影剂的需求，II期项目将优化铁基造影剂，该铁基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。研究目标包括：（1）优化最小可行产品，以降低剂量并增强安全性;（2）评价诊断成像功效和毒理学;以及（3）证明用于合成最终制剂的放大生产工艺。该解决方案解决了降低商业化风险并使技术更接近市场所需的主要问题。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值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.