Gadopiclenol (Elucirem): A New Gadolinium Based Contrast Agent With High Relaxivity for Increased Contrast and Improved Differentiation of Clinically Significant Prostate Cancer on Contrast Enhanced MRI: A Prospective Study.
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Blinded Radiology Review of Enhancement of Images, Graded 1-5
研究概览
简要总结
The fundamental aim of this study is to show that the novel contrast agent Gadopiclenol (Elucirem), with its high relaxivity, facilitates increased contrast enhancement and improved differentiation of clinically significant prostate cancer on Prostate MRI, as categorized by the PI-RADS v2 classification categories.
详细描述
Gadolinium based contrast agents with higher relaxivity have been shown to improve contrast enhancement and differentiation of tissues with increased blood perfusion or with higher microvascular density (MVD), and therefore increase visibility of cancerous tissue. In this study, the objective is to demonstrate that Gadopiclenol facilitates the detection and classification of clinically significant prostate cancer, compared to T2-W (T2 weighted image) and diffusion weighted imaging (DWI), using the detailed location-specific (individual biopsy core for each annotated target) results of subsequently performed MRI-US fusion biopsies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo a clinically indicated MRI of the prostate with contrast.
- •Scheduled to undergo, or likely to be scheduled to undergo, a prostate MRI-US fusion biopsy with histology results available within 6 months of their MRI.
排除标准
- •Have already begun therapeutic treatment for prostate cancer including surgery (TURP, prostatectomy), radiotherapy, hormone therapy or chemotherapy.
- •Patients with end stage renal failure who are on dialysis. Patients who have chronic kidney disease or acute kidney injury are contraindicated for MRI per FDA and ACR (American College of Radiologists) guidelines and would thus be excluded as well.
研究组 & 干预措施
Gadopiclenol
Patients who are scheduled for clinical care MRI Prostate scans with Gadopiclenol.
Gadopiclenol is FDA-approved for this indication. Gadopiclenol for contrast enhanced MRI - recommended dose for adult is 0.05 mmol/kg actual body weight. The dose is the weight-based dosage regime that is indicated on the package insert.
干预措施: Gadopiclenol (Drug)
结局指标
主要结局
Blinded Radiology Review of Enhancement of Images, Graded 1-5
时间窗: Through Study Completion (An Average of 1 Year Post-MRI)
Single qualitative grade for contrast enhancement quality, with each exam being graded on a scale of 1-(Fail) to 5-(Excellent) contrast enhancement quality.
次要结局
- Quantitative Measurements of Wash-In/Wash-Out Contrast Curve(Through Study Completion (An Average of 1 Year Post-MRI))
研究者
Nicolas Bloch
Professor of Radiology
Columbia University