Commercialization of an MRI contrast agent for differential diagnosis of prostate cancer.
用于前列腺癌鉴别诊断的 MRI 造影剂的商业化。
基本信息
- 批准号:9534548
- 负责人:
- 金额:$ 99.97万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2015
- 资助国家:美国
- 起止时间:2015-07-21 至 2021-04-30
- 项目状态:已结题
- 来源:
- 关键词:Adverse effectsAffinityAggressive behaviorAnimal ModelAppearanceBindingBiodistributionBiopsyBlood ScreeningCancer EtiologyCarcinomaCellsCessation of lifeClinicalClinical DataClinical ManagementClinical TrialsContrast MediaDataDecision MakingDetectionDevelopmentDiagnosisDiagnostic ImagingDiagnostic ProcedureDifferential DiagnosisDiseaseDisease ProgressionDoseDrug KineticsEarly DiagnosisEffectivenessErectile dysfunctionExtracellular MatrixFDA approvedFormulationFreeze DryingGoalsHourHumanImageryImaging TechniquesImaging technologyIndolentIntestinesLeadLesionLethal Dose 50LocationMagnetic Resonance ImagingMalignant NeoplasmsMalignant neoplasm of prostateMetabolic Clearance RateMethodsMissionModelingMolecularMolecular TargetMonitorMusNeoplasm MetastasisNo-Observed-Adverse-Effect LevelNoiseNormal tissue morphologyOncoproteinsOperative Surgical ProceduresOsmolalitiesPC3 cell linePatientsPharmacologyPhasePhysiciansPlasmaProductionProhanceProstateProstate Cancer therapyProstate-Specific AntigenProstatic NeoplasmsProteinsRadiationRattusRenal clearance functionResidual stateRiskRisk stratificationRodentSafetyScreening for Prostate CancerSensitivity and SpecificitySmall Business Innovation Research GrantStructureTemperatureTestingTimeTissuesToxic effectUltrasonographyUrinary IncontinenceUrologistWaterXenograft procedureactive methodangiogenesisaqueousbasecancer cellcancer imagingcancer riskclinical diagnosticsclinical imagingclinical translationcommercializationcontrast enhancedcost effectiveepithelial to mesenchymal transitionhigh resolution imaginghigh riskimage guided therapyimaging agentimaging approachimprovedinnovationmenmolecular imagingmortalitynoveloverexpressionpreclinical studypreventprocedure costprostate biopsyprostate cancer riskreconstitutionsafety studyscale upscreeningstemnesstheranosticstherapy outcometooltumor
项目摘要
Abstract
Prostate cancer is a highly heterogeneous disease and the second most cause of cancer death of
men in the US. Current methods to assess prostate cancer risk combine prostate specific antigen (PSA)
screening and random prostate biopsy. Unfortunately, this strategy fails to reveal the lesion’s location and
does not accurately differentiate between aggressive and non-aggressive prostate cancers. As a result,
most patients will receive unnecessary active treatment for low-risk prostate cancer in order to avoid
under treatment. Active treatment involves surgery or radiation, often causing long-term side effects such
as urinary incontinence, erectile dysfunction, or bowel urgency. Thus, development of non-invasive and
accurate diagnostic imaging technology to localize and differentiate high-risk prostate cancer offer a new
tool to assist physicians in risk-stratification and decision making and to spare millions patients with low-
risk cancer from unnecessary aggressive treatment.
The mission of Molecular Theranostics (fka Prostate Theranostics) is to commercialize a novel
molecular imaging approach that targets an oncoprotein associated with epithelial-to-mesenchymal
transition (EMT), cancer cell stemness, angiogenesis, proliferation, and metastasis. The oncoprotein has
a high expression in the tumor extracellular matrix of high-risk prostate cancer, low in low-grade tumor,
none in normal tissues. The goal of this project is to commercialize a safe and effective targeted contrast
agent for accurate early detection, localization, and differential diagnosis of high-risk prostate cancer with
MRI. In phase I, we have optimized and identified a lead targeted MRI contrast agent for clinical
translation. All of the milestones in Phase I of the project have been achieved. The agent possesses the
superior ability of robust specific contrast enhancement in high-risk prostate cancer, not in slow growing
low-risk tumors in animal models, and has the potential to visualize and differentiate high-risk prostate
cancers with MRI.
The objectives of this SBIR Phase II are to develop a lead formulation of the contrast agent, to
perform FDA required eIND enabling studies, and to commercialize the agent for clinical imaging prostate
cancer. The specific aims are 1) to scale up the synthesis of the targeted contrast agent and develop a
lead product formulation for pre-clinical study and clinical trials; 2) to validate the effectiveness of the
formulation for prostate cancer imaging on a clinical MRI scanner and to determine its minimally effective
dose; 3) to perform eIND-enabling pharmacokinetics and safety studies in rodents. Non-invasive accurate
detection of prostate cancer is an unmet clinical need for prostate cancer management. Clinical trials will
be initiated as soon as the eIND is approved by the FDA. Successful development of our imaging
technology has the potential to accurately detect, localize, and diagnose prostate cancer, replace
invasive prostate biopsy, and improve decision-making in clinical management of prostate cancer. It also
has the potential for non-invasive active surveillance of prostate cancer and timely monitoring of disease
progression, as well as image-guided therapy.
摘要
前列腺癌是一种高度异质性的疾病,是导致癌症死亡的第二大原因。
美国的男人。目前评估前列腺癌风险的方法是结合前列腺特异性抗原(PSA)
筛查和随机的前列腺活检。不幸的是,这一策略未能揭示病变的位置和
不能准确区分侵袭性和非侵袭性前列腺癌。结果,
大多数患者将接受不必要的积极治疗低风险前列腺癌,以避免
正在接受治疗。积极的治疗包括手术或放射治疗,通常会导致长期的副作用,如
如尿失禁、勃起功能障碍或肠道紧迫症。因此,非侵入性和非侵入性
准确的诊断成像技术定位和鉴别高危前列腺癌提供了一种新的
帮助医生进行风险分层和决策的工具,并使数百万患者免受低风险风险的困扰
不必要的激进治疗有患癌症的风险。
分子遗传学(FKA)的使命是将一种新的
靶向上皮间充质相关癌蛋白的分子成像方法
转移(EMT)、癌细胞干性、血管生成、增殖和转移。癌蛋白有
在高危前列腺癌的肿瘤细胞外基质中高表达,在低级别前列腺癌中低表达,
在正常组织中不存在。该项目的目标是将一种安全有效的靶向对比剂商业化
用于早期准确发现、定位和鉴别诊断高危前列腺癌的试剂
核磁共振检查。在第一阶段,我们优化并确定了一种用于临床的铅靶向mri造影剂。
翻译。该项目第一阶段的所有里程碑都已实现。该代理拥有
在高危前列腺癌而不是生长缓慢的前列腺癌中增强强大的特异性对比剂的能力
动物模型中的低风险肿瘤,并有可能可视化和区分高危前列腺癌
用核磁共振检查癌症。
此SBIR第二阶段的目标是开发造影剂的先导配方,以
执行FDA要求的EIND使能研究,并将用于临床前列腺癌成像的试剂商业化
癌症。其具体目标是1)放大靶向造影剂的合成,并开发一种
用于临床前研究和临床试验的主导产品配方;2)验证
前列腺癌在临床MRI扫描仪上的成像配方及其最低有效值的确定
剂量;3)在啮齿动物身上进行EIND药代动力学和安全性研究。无创准确
前列腺癌的检测是前列腺癌治疗中尚未得到满足的临床需求。临床试验将
一旦FDA批准了EIND,就可以立即启动。我们的成像技术的成功开发
技术有可能准确地检测、定位和诊断前列腺癌,取代
侵入性前列腺活检,提高前列腺癌临床治疗的决策能力。它还
有可能对前列腺癌进行非侵入性主动监测并及时监测疾病
进展,以及影像引导治疗。
项目成果
期刊论文数量(0)
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Yajuan Li其他文献
Yajuan Li的其他文献
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{{ truncateString('Yajuan Li', 18)}}的其他基金
Commercialization of an MRI contrast agent for differential diagnosis of prostate cancer
用于前列腺癌鉴别诊断的 MRI 造影剂的商业化
- 批准号:
10481722 - 财政年份:2022
- 资助金额:
$ 99.97万 - 项目类别:
Commercialization of an MRI contrast agent for differential diagnosis of prostate cancer.
用于前列腺癌鉴别诊断的 MRI 造影剂的商业化。
- 批准号:
10013075 - 财政年份:2015
- 资助金额:
$ 99.97万 - 项目类别:
Commercialization of an MRI contrast agent for differential diagnosis of prostate cancer.
用于前列腺癌鉴别诊断的 MRI 造影剂的商业化。
- 批准号:
9984635 - 财政年份:2015
- 资助金额:
$ 99.97万 - 项目类别:
Commercialization of targeted MRI contrast agents for prostate cancer imaging.
用于前列腺癌成像的靶向 MRI 造影剂的商业化。
- 批准号:
8979024 - 财政年份:2015
- 资助金额:
$ 99.97万 - 项目类别:
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