99mTc-MIP-1404 for Imaging Prostate Cancer: Phase I Clinical Study to Assess the Image Quality of a Simplified Kit Formulation Compared to a Multi-step Preparation of 99mTc-MIP-1404
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To assess the image quality of a simplified kit formulation of 99mTc-MIP-1404 (study drug) compared to a multi-step preparation of 99mTc-MIP-1404 in patients with confirmed metastatic prostate adenocarcinoma and in healthy volunteers
研究概览
简要总结
This trial is a single-blind, cross-over design. Up to three patients with confirmed metastatic prostate adenocarcinoma and up to three healthy volunteers will receive two doses of 20.0 (± 3) mCi of intravenously administered 99mTc MIP 1404 (preparation A or preparation B). Whole-body planar scintigraphic images will be acquired at various time points on the day of study drug administration. A pelvic SPECT/CT image will be acquired on the day of study drug administration. Blood will be collected for pharmacokinetic measurements following study drug administration. Each participant will receive an initial study drug administration (preparation A) and a second study drug administration (preparation B) approximately 7 to 21 days later. A final follow-up visit will occur approximately 2 - 3 weeks after the second study drug administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male aged 21 years or older.
- •Ability to provide signed informed consent and willingness to comply with protocol requirements.
- •Participants must agree to use an acceptable form of birth control throughout the study period. Participants must agree to use condoms for a period of seven days after each study drug administration, if engaged in sexual activity.
- •Additional Inclusion Criteria for Metastatic Prostate Adenocarcinoma Patients:
- •Histologic diagnosis of prostate cancer by validated medical history (pathology report, if available).
- •Evidence of metastatic disease demonstrated by a documented abnormal bone scan, CT scan, or MRI
- •Karnofsky performance is ≥ 60
- •Additional Inclusion Criteria for Healthy Volunteers:
- •PSA laboratory assessment within normal range (PSA < 4 ng/ml)
- •Normal findings on a digital rectal examination
- •Hemoglobin and hematocrit within normal range
排除标准
- •Received a radioisotope within 5 physical half lives of that radioisotope prior to study enrollment
- •Have any medical condition or other circumstances which, in the opinion of the Investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations
- •Participant is determined by the Investigator to be clinically unsuitable for the study
- •Serum creatinine ≥ 2.0 mg/dl
- •Total bilirubin ≥ 2.0 mg/dl
- •Liver transaminases ≥ 1.5 x ULN
- •Platelet count < 100,000/mm3
- •Absolute neutrophil count (ANC) < 2,000/mm3
- •Hematocrit < 30% or hemoglobin < 10 g/dl
- •Additional Exclusion Criteria for Metastatic Prostate Adenocarcinoma Patients:
- •Have received a permanent prostate brachytherapy implant within the last 3 months for 103Pd implants; or 12 months for 125I implants
- •Have had any other malignancies within the past year, other than basal or squamous cell carcinoma of the skin, in which the diagnosis and location have not been defined as clinically controlled or treated to complete response
研究组 & 干预措施
Preparation A
20 (±3) mCi 99mTc-MIP-1404 (preparation A)
干预措施: 99mTc-MIP-1404 (Drug)
Preparation B
20 (±3) mCi 99mTc-MIP-1404 (preparation B)
干预措施: 99mTc-MIP-1404 (Drug)
结局指标
主要结局
To assess the image quality of a simplified kit formulation of 99mTc-MIP-1404 (study drug) compared to a multi-step preparation of 99mTc-MIP-1404 in patients with confirmed metastatic prostate adenocarcinoma and in healthy volunteers
时间窗: Whole-body planar scintigraphic images will be acquired at 30 min, 2 and 4 hours post administration. A pelvic SPECT/CT image will be acquired at 3 hours post study drug administration
次要结局
- To determine the pharmacokinetics, biodistribution and tumor uptake of 99mTc-MIP-1404 preparations in patients with confirmed metastatic prostate adenocarcinoma and in healthy volunteers(Blood will be collected for PK and radioactivity counting at baseline, 2 minutes, 5 minutes, 30 minutes, 1 hour, 2 hours, and 4 hours post study drug administration.)