Early Post-transplant Contrast-enhanced Abdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Incidence of contrast related nephropathy
研究概览
简要总结
Contrast-enhanced abdominal CT will be performed 1-2 weeks after allogeneic stem cell transplant, and radiographic evidence of mucosal inflammation will be correlated with the subsequent development of acute graft versus host disease. The primary endpoint is the feasibility and safety of contrast-enhanced abdominal CT in the early post-transplant period, as defined by the risk of contrast-related nephropathy or allergic reaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven diagnosis of a hematologic malignancy
- •Scheduled to undergo allogeneic SCT from a matched sibling donor or an unrelated donor who is 10/10 or 9/10 HLA match. Transplant eligibility is per standard and institutional criteria.
- •Age 18-60 years
- •Willing and able to provide informed consent
排除标准
- •Documented or reported contrast allergy
- •Estimated glomerular filtration rate (GFR) < 60
- •Deemed too sick by clinician to leave the floor for imaging
- •"Nothing-per-mouth" status for other clinical reasons
- •Inclusion of Women and Minorities
- •Both men and women and members of all races and ethnic groups are eligible for this trial.
研究组 & 干预措施
CT scan with contrast
干预措施: Dynamic contrast-enhanced computed tomography (Radiation)
CT scan with contrast
干预措施: Ioversol (Drug)
结局指标
主要结局
Incidence of contrast related nephropathy
时间窗: Baseline through 72 hours after intravenous contrast administration
Contrast related nephropathy is defined as \>25% increase in serum creatinine from baseline (day of CT) or 0.5 mg/dL increase in absolute value, within 48-72 hours of intravenous contrast administration. Assessed using the National Cancer Institute Common Criteria for Adverse Events (NCI CTCAE) Version 4.0. The proportion of patients who develop contrast nephropathy will be recorded.
Incidence of contrast allergic reaction
时间窗: Within 4 hours after contrast administration
Assessed using the National Cancer Institute Common Criteria for Adverse Events (NCI CTCAE) Version 4.0. The proportion of patients who an allergic reaction will be recorded.
次要结局
- Correlation between CT risk scores and occurrence of acute GVHD(180 days)