Development and Clinical Translation of Protein-losing Enteropathy (PLE) Imaging PET Probe
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Standard Uptake Value Value
研究概览
简要总结
In this project, based on the DTPA-HAS kit, investigators plan to develop a positron nuclide 68Ga labeled DTPA-HSA molecular probe in order to obtain high sensitivity, signal-to-noise ratio and high-resolution PET/CT imaging images, aiming to find the specific site of intestinal leakage while diagnosing Protein-Losing Enteropathy (PLE), and analyze the pathological mechanism of intestinal leakage in combination with pathology, so as to provide molecular imaging guidance for the treatment of PLE patients. PLE is a rare gastrointestinal protein-losing syndrome, and the radiopharmaceutical 99mTc-DTPA-HSA (99mTc-human serum albumin) approved by the State Food and Drug Administration has the diagnostic ability of protein-losing enteropathy (PLE), but due to the low resolution of SPECT/CT, the image clarity and signal-to-noise ratio need to be improved, it is a classic probe in the last century, unable to meet the existing clinical needs.
详细描述
This project developed a a new type of nuclide Ga-68 labeled DTPA-HSA probe, and with the inherent advantages of this nuclear medicine department, it has promoted the formulation of the production filing standard of the drug, and obtained the 68Ga-HSA injection that can be used for preclinical research and meets the clinical standards. Clinical research on 68Ga-HSA PET/CT imaging was carried out to provide a basis for the diagnosis and treatment of PLE patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with digestive system tumors;
- •Presence of hypoproteinemia or clinical manifestations of hypoplasma protein;
- •Serum albumin <30 g/L, AAT>80 ml/d;
- •Measurable lesions in imaging;
- •Predicted survival greater than 3 months;
排除标准
- •Severe hepatic or renal dysfunction;
- •Pregnant or nursing;
- •Known allergy to the investigational drug or its excipients in study;
- •Unable to comply with the PET/CT imaging procedures;
- •Claustrophobia or other psychiatric disorders;
- •Other conditions deemed unsuitable for participation in the trial;
研究组 & 干预措施
68Ga-HSA PET/CT in participants with hypoproteinemia
Participants who are with hypoproteinemia will be injected with 2.22 MBq/kg body weight of 68Ga-HSA in one dose intravenously and then undergo PET/CT scan within 1 h.
干预措施: 68Ga-HSA (Drug)
结局指标
主要结局
Standard Uptake Value Value
时间窗: 1 year
The standardized uptake value(SUV) of 68Ga-HSA in suspected PLE lesions measured by the PET/CT
SUVR
时间窗: 1 year
Ratio of the SUV of 68GA-DTPA-HSA in the suspected PLE lesions to the SUV of 68Ga DTPA-HSA in the normal tissues corresponding to the PLE (SUVR)
次要结局
未报告次要终点