PET Imaging of Subjects Using 124I-PU-AD: A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Pharmacokinetic profile of 124I-PU-AD: maximum plasma concentration (Cmax)
研究概览
简要总结
This is a first in-human, open-label pilot (microdose) study of the positron-emitting agent 124I-PU-AD in subjects with specific cancer types (solid malignancy, lymphoma, and/or myeloma) and/or Alzheimer's disease.
详细描述
This first in-human trial of the positron-emitting agent 124I-PU-AD is an open-label pilot (microdose) study. Up to 10 evaluable subjects who have active disease will be enrolled to evaluate the PK, metabolism, biodistribution, and radiation dosimetry of 124I-PU-AD.
Following a 28-day screening period, eligible subjects will return to the clinic on Day 1. A single dose of 124I-PU-AD will be administered by intravenous (IV) injection to subjects.
After 124I-PU-AD tracer injection, PET scans will be performed at 4 time points. At each time-point, an axial body image is acquired on a state-of-the-art PET-CT scanner. A low-dose CT will be obtained immediately-prior to PET imaging, at each time-point. Serial blood samples will also be obtained at multiple time points.
Subjects will be evaluated to ensure that there are no clinically significant ongoing AEs prior to discharge.
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
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a diagnosis of cancer and/or Alzheimer's Disease, meeting trial eligibility criteria as specified below for either disease:
- •Subjects with eligible histologic types of cancer. Eligible histologic types of cancer include solid malignancy, myeloma, and lymphoma.
- •Cancer histology confirmed by pathology.
- •Cancerous disease is radiologically-measurable or evaluable as defined by published tumor response criteria (including but not limited to RECIST 1.1).
- •Alzheimer's:
- •Established diagnosis of mild-moderate Alzheimer's disease based upon neurological and neuropsychological evaluation following the National Institute on Aging - Alzheimer's disease Association criteria that recently revisited the NINCDS-ADRDA criteria.
- •Documentation of diagnosis of mild-moderate Alzheimer's disease, as above, by board-certified neurologist.
- •Subjects who have both cancer and Alzheimer's Disease, subjects are considered eligible if they meet all eligibility requirements for either Alzheimer's Disease or cancer patients, as specified above.
排除标准
- •Subject has unacceptable pre-study organ function during screening defined as:
- •Bilirubin > 1.5 x institutional upper limit of normal (ULN)
- •AST/ALT >2.5 x ULN
- •Albumin < 2 g/dl
- •GGT > 2.5 x ULN (IF Alkaline phosphatase > 2.5 x ULN)
- •Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min.
- •Subject has history of acute major illness (i.e., unstable cardiovascular condition.)
- •Subject has concurrent participation in any interventional studies within 30 days of first dose of study drug.
研究组 & 干预措施
124I-PU-AD
A single dose of 124I-PU-AD will be administered by intravenous (IV) injection
干预措施: PU-AD (Drug)
124I-PU-AD
A single dose of 124I-PU-AD will be administered by intravenous (IV) injection
干预措施: PET Scan (Device)
124I-PU-AD
A single dose of 124I-PU-AD will be administered by intravenous (IV) injection
干预措施: Blood Draws (Other)
结局指标
主要结局
Pharmacokinetic profile of 124I-PU-AD: maximum plasma concentration (Cmax)
时间窗: 1 week
Pharmacokinetic profile of 124I-PU-AD: trough plasma concentration (Cmin)
时间窗: 1 week
Pharmacokinetic profile of 124I-PU-AD: time to maximum plasma concentration (Tmax)
时间窗: 1 week
Pharmacokinetic profile of 124I-PU-AD: area under the curve (AUC)
时间窗: 1 week
Pharmacokinetic profile of 124I-PU-AD: plasma half-life (T1/2)
时间窗: 1 week
次要结局
- Incidence of adverse events(30 days)