A Single-center, Evaluator-blinded Clinical Study of Polysaccharide Superparamagnetic Iron Oxide Injection for Magnetic Resonance Venography in Patients With Venous System Diseases
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Overall Diagnostic Success Rate
研究概览
简要总结
The purpose of this single-center, prospective, evaluator-blinded study is to establish and optimize the imaging protocol for ferumoxytol-enhanced magnetic resonance venography (Fe-MRV) in patients with venous system diseases.
Current gadolinium-based contrast agents used in MRI have limitations, including short circulation half-lives and potential risks for patients with renal impairment. Ferumoxytol, a superparamagnetic iron oxide nanoparticle, offers a longer imaging window and no renal toxicity, making it a promising alternative for vascular imaging.
This study will enroll 50 adult patients with suspected or confirmed venous structural abnormalities or circulation disorders. To determine the minimum effective diagnostic dose, each participant will receive a total dose of 3.0 mg/kg, administered as four equal intravenous aliquots, with MRI performed after each aliquot (cumulative doses: 0.75, 1.50, 2.25, and 3.0 mg/kg). Independent, blinded radiologists will evaluate the image quality at each cumulative dose level to determine the lowest possible dose required to achieve successful clinical diagnosis.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years.
- •Suspected or preliminarily diagnosed venous structural abnormalities (e.g., lower-extremity veins, central veins) or venous circulation disorders requiring Fe-MRV evaluation.
- •Able and willing to provide written informed consent.
排除标准
- •History of allergy/hypersensitivity to iron or dextran, or known allergy-prone constitution.
- •Currently receiving other oral or intravenous iron products.
- •Hemosiderosis or hemochromatosis.
- •Prior hypersensitivity reaction to intravenous iron products, or any condition associated with iron overload.
- •Unable to undergo MRI for psychological reasons (e.g., claustrophobia) or physical reasons (e.g., non-MRI-compatible metallic implants/foreign bodies).
- •End-stage disease or life expectancy < 1 year.
- •Pregnant women.
- •Any other condition judged by the investigator to make the participant unsuitable for the study.
研究组 & 干预措施
Fe-MRV Dose Optimization Group
All enrolled participants will receive a total dose of 3.0 mg/kg of ferumoxytol injection. The contrast agent is administered intravenously in four equal consecutive aliquots. An MRI scan is performed after each aliquot to evaluate image quality at cumulative doses of 0.75, 1.50, 2.25, and 3.0 mg/kg.
干预措施: Ferumoxytol injection (Drug)
结局指标
主要结局
Overall Diagnostic Success Rate
时间窗: Up to 2 days post-intervention
The overall diagnostic success rate is defined as the proportion of vascular segments with an average image quality score of ≥ 3 (evaluated on a 5-point Likert scale, where 1 = non-diagnostic/unusable and 5 = excellent). A segment is considered successfully diagnosed only if two independent, blinded radiologists reach a consensus that it is "diagnosable".
次要结局
- Signal-to-Noise Ratio (SNR) Assessed by Ferumoxytol-enhanced Magnetic Resonance Venography(Up to 2 days post-intervention)
- Contrast-to-Noise Ratio (CNR) Assessed by Ferumoxytol-enhanced Magnetic Resonance Venography(Up to 2 days post-intervention)
研究者
Min Zhou
Chief Physician (Vascular Surgery)
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School