Dynamic Positron Emission Tomography Imaging With 11C-ER176 to Delineate Macrophage Activation in Diabetic Gastroparesis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Uptake of 11C-ER 176 in the Stomach Muscle
研究概览
简要总结
Macrophage-driven immune dysregulation has been shown to be involved in pathophysiology of diabetic gastroparesis. Currently, there are no non-invasive ways to study macrophage activation in humans. The researchers are trying to determine the utility of 11C-ER176 based PET-CT scanning to determine pro-inflammatory macrophage activation in gastric wall of patients with diabetic gastroparesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 18 to 70 years of age.
- •Ability to provide informed consent.
- •Type I or II diabetes mellitus.
- •Gastroparesis defined by gastric retention of Tc-99m > 60 % at 2 hrs and/or > 10% at 4 hours on scintigraphy.
- •Average Gastroparesis Cardinal Symptom Index (GCSI) ≥ 3 indicating moderate-severe symptoms.
排除标准
- •Women who are pregnant or cannot stop breast feeding for 24 hours.
- •Using anti-coagulants, anti-inflammatory medications (NSAIDs, corticosteroids, etc.) or immunosuppressive therapies within the 4 weeks prior.
- •Opioid use within the last 4 weeks of gastric emptying scintigraphy.
- •Prior gastric surgery.
- •History of IBD, celiac disease, eosinophilic gastroenteritis, microscopic colitis.
- •Healthy Subjects Exclusion criteria
- •no clinical history of diabetes or any GI symptoms
- •no inflammatory disorders of the GI tract
- •no use of anti-inflammatory or immunosuppressive therapies
研究组 & 干预措施
Diabetic Gastroparesis Subjects
Type I or II diabetes subjects who also have a diagnosis of Gastroparesis (defined by gastric retention of Tc-99m >20% at 4 hrs on scintigraphy). Subjects will receive PET/CT Scan with 11C-ER176 and a core biopsy of gastric muscle
干预措施: PET/CT Scan with 11C-ER176 (Drug)
Diabetic Gastroparesis Subjects
Type I or II diabetes subjects who also have a diagnosis of Gastroparesis (defined by gastric retention of Tc-99m >20% at 4 hrs on scintigraphy). Subjects will receive PET/CT Scan with 11C-ER176 and a core biopsy of gastric muscle
干预措施: Core biopsy of gastric muscle (Diagnostic Test)
Diabetic without gastroparesis subjects
Type I or II diabetes subjects who have not been clinically diagnosed with Gastroparesis. Subjects will receive PET/CT Scan with 11C-ER176
干预措施: PET/CT Scan with 11C-ER176 (Drug)
Healthy Subjects
Healthy subjects will be age-matched and receive a PET/CT Scan with 11C-ER176
干预措施: PET/CT Scan with 11C-ER176 (Drug)
结局指标
主要结局
Uptake of 11C-ER 176 in the Stomach Muscle
时间窗: baseline
All patients will have a PET/CT with 11C-ER 176. On each PET image, volumes of interest areas will be drawn around the stomach and other organs that may show radiotracer accumulation. The uptake of radiotracer 11C-ER 176 in each area will be quantified and reported as maximum standardized uptake values (SUVmax)
次要结局
- Percentage of Immune Cells With CD45 Expression(baseline)
研究者
Madhusudan (Madhu) Grover, MBBS
Principal Investigator
Mayo Clinic