Ferumoxytol Contrast for the MRI Imaging of Osteomyelitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- contrast changes
研究概览
简要总结
Diabetic foot infections contribute to 75,000 hospitalizations in the US each year. There is a lifetime incidence of 15-25% of foot infections in diabetics. The investigators hypothesize that ferumoxytol (FDA approved for use in CKD patients, unlike gadolinium) will improve the accuracy of MR imaging in the diagnosis of osteomyelitis by allowing for the specific imaging of macrophages that have taken up the iron-based compound. In this study the investigators will image 12 patients with suspected diabetic osteomyelitis using ferumoxytol-contrasted MRI, and evaluate the feasibility of this approach.
详细描述
Prior to enrollment, patients will get baseline labs to ensure they are candidates for the study. These will include a pregnancy test (if not previously acquired within 1 week of enrollment in study), basic metabolic panel (if not already obtained within 48 hours of enrollment), a complete blood count (if not already obtained within 48 hours of enrollment), and a hemoglobin A1C (If not obtained within 4 weeks prior to enrollment).
MRI will be performed, and standard precautionary measures for MRI imaging will be followed.
Patients with a GFR below 40 or AKI (based on clinical suspicion in accordance with standard UNM protocols for contraindications to gadolinium): Will obtain non-contrasted baseline MRI. Within 72 hours of baseline MRI, patients will obtain ferumoxytol contrasted MRI (6 patients).
Patients with a GFR above 40 and no AKI: Will get an MRI with and without gadolinium contrast on day 0 and ferumoxytol contrasted MRI within 72 hours (6 patients).
T1 with fat sat three planes, T2* and T2 with fat sat three planes will be obtained on a UNM MRI machine. FLASH sequences will also be obtained.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
study group
Patients will receive Ferumoxides 11.2Mg Solution for Injection.
干预措施: Ferumoxides 11.2Mg Solution for Injection (Drug)
结局指标
主要结局
contrast changes
时间窗: 6 weeks
To measure the contrast changes of osteomyelitis on ferumoxytol-contrasted MRI.
次要结局
- ferumoxytol-enhanced MRI(6 weeks)
- signal to noise ratio (SNR) difference and relative enhancement (RE)(6 weeks)
- positive anti-dextran coating(6 weeks)
- Worsening osteomyelitis infection(24 hours)