NCT01269593进行中（未招募）早期 1 期
PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- To study the pharmacokinetics
研究概览
简要总结
The purpose of this study is to see how a new drug, named PUH71, accumulates in the different parts of the body & inside tumors and how long PUH71 lasts in the blood, when given to study participants in tiny amounts. The results of this study will help researchers (1) plan how they will use PUH71 as an experimental new drug (at much-higher doses) for the treatment of cancer, in clinical trials; and (2) know whether PUH71 might be used as a drug for detecting tumors with scanner machines.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma (histology confirmed by MSKCC Department of Pathology)
- •Disease is measurable or evaluable as defined by RECIST (1.1 or original version) or other tumor response criteria from an MSKCC IRB-approved clinical research protocol.
- •This does not apply to patients with myeloproliferative neoplasm. The presence of active myeloproliferative neoplasm will be determined by applicable disease specific diagnostic criteria and patient assessment by the patient's oncologist and trial investigators (eg, manifestations of active MPN such as splenomegaly, abnormal blood counts, etc).
- •Age between 18-90
- •Negative serum pregnancy test for females of childbearing age (11-55 years) and/or lack child-bearing potential
- •No breast-feeding
排除标准
- •Previous allergic reaction to contrast medium.
- •Hypersensitivity to iodide products.
- •Known hyperthyroidism
- •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. Renal: Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min.
- •Positive serum pregnancy test for females
- •Acute major illness (e.g., infection, unstable cardiovascular condition, etc.)
研究组 & 干预措施
PET Imaging Using 124 IPUH71
Experimental
Patients will receive an injection of up to 11.0 mCi (range: 4.0-11.0 mCi) of 124I-PUH71, followed by serial PET scanning and blood draws, over a period of 3 days. Optional with a fourth day of PET scanning is to be pursued, in willing patients.
干预措施: PET Imaging using 124 IPUH71 (Drug)
结局指标
主要结局
To study the pharmacokinetics
时间窗: 2 years
of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma.
次要结局
- To study the metabolism(2 years)
- To study the biodistribution(2 years)
- To study the radiation dosimetry(2 years)
研究者
研究点 (1)
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