[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects
概览
- 阶段
- 1 期
- 干预措施
- [18F]fluoropropyl-trimethoprim
- 疾病 / 适应症
- Bacterial Infections
- 发起方
- University of Pennsylvania
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Understand the biodistribution of F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
The purpose of this study is to study a radioactive tracer, a type of imaging drug that is injected into the body to see how it is taken up in sites of active infection using an imaging procedure called Positron Emission Tomography/Computed Tomography (PET/CT).
研究者
入排标准
入选标准
- •At least 18 years of age
- •Known or suspected bacterial infection, per clinical documentation of suspected infection (e.g. lab results, pathology results, physician progress notes, clinical symptoms of infection)
- •Able to understand the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures
排除标准
- •Antibiotic therapy with trimethoprim within 48h of the baseline PET/CT scan
- •Inability to tolerate imaging procedures, in the opinion of an investigator or treating physician
- •Unstable or other severe medical or psychological comorbidities that would compromise the subject's safety or successful participation in the study, in the opinion of an investigator or treating physician
- •Pregnant or breast feeding patients; a urine pregnancy test will be performed in women of child-bearing potential prior to \[18F\]F-TMP injection, to confirm non-pregnant status
研究组 & 干预措施
Biodistribution cohort
The Biodistribution cohort will include up to 5 patients who will undergo a series of vertex to mid-thigh (or feet if indicated) biodistribution \[18F\]fluoropropyl-trimethoprim PET/CT scans over a period of approximately 4 hours.
干预措施: [18F]fluoropropyl-trimethoprim
The Dynamic cohort
The Dynamic cohort will include up to 15 patients who will undergo approximately 60 minutes of dynamic scanning followed by up to 2 static skull base to mid-thigh (or feet if indicated) scans post injection of \[18F\]fluoropropyl-trimethoprim.
干预措施: [18F]fluoropropyl-trimethoprim
结局指标
主要结局
Understand the biodistribution of F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans
时间窗: 3 year
Understand the biodistribution of F-TMP in human patients by comparing the F-TMP uptake using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads.
Understanding the kinetics of uptake of [18F]F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans
时间窗: 3 years
Understanding the the kinetics of uptake of \[18F\]F-TMP in human patients by comparing the F-TMP uptake using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads.
次要结局
- Describe the change in kinetics of uptake of [18F]F-TMP in human patients after therapy.(3 year)
- Compare the uptake of [18F]F-TMP in infected versus non-infected tissues using PET/CT scans.(3 year)
- Describe the change in biodistribution of uptake of [18F]F-TMP in human patients after therapy.(3 year)