A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111In Capromab Pendetide in Subjects With Metastatic Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 7
- 主要终点
- Estimate the imaging sensitivity and specificity of 10.0 mCi or 5.0 mCi of 123I MIP 1072 compared to 5 mCi of 111In capromab pendetide in subjects with metastatic prostate cancer by determining the presence and extent of the disease.
研究概览
简要总结
This is an open-label study comparing the imaging characteristics of 123-I-MIP-1072 and ProstaScint® (111-In-capromab pendetide)in patients with metastatic prostate cancer. Eligible patients will receive a dose of 123-I-MIP-1072 and have imaging studies and safety assessments (physical examination, vital signs, electrocardiogram, clinical laboratory tests) performed during the subsequent 24 hours. Two weeks later, patients will return for additional safety assessments and will receive ProstaScint® if they don't already have a pre-existing ProstaScint scan. Final assessments will be performed two weeks after the ProstaScint® scan unless there is a difference between the 123-I-MIP-1072 and ProstaScint® scans. If this is the case, another dose of 123-I-MIP-1072 will be given 12 weeks later, and imaging studies repeated.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Karnofsky performance status of < 50
- •Subject has received a permanent prostate brachytherapy implant within the last 3 months for 103Pd implants or 12 months for 125I implants
- •Subject was administered a diagnostic radioisotope within 5 physical half lives of that radioisotope prior to study enrollment
- •Subject has received an investigational compound and/or medical device or has been part of an investigational study within the past 30 days before enrollment into this study
- •Any treatment with radiopharmaceuticals, e.g. Strontium 89 and Samarium 153 within 6 months prior to enrollment
- •Ketoconazole or anti androgens (flutamide, nilutamide, bicalutamide) within 4 weeks prior to enrollment. Patients who demonstrate an antiandrogen withdrawal response, defined as a > 25% drop in PSA within 4 weeks (flutamide) or 6 weeks (nilutamide, bicalutamide) of stopping a non steroidal anti androgen, are not eligible until the PSA rises above the nadir observed after anti androgen withdrawal
- •Initiation of bisphosphonate therapy within 28 days prior to enrollment. Patients taking bisphosphonates should not have their dosing regimen altered unless medically warranted in the interval between baseline scans and end of study
- •Subject has 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
- •Subject is determined by the Investigator to be clinically unsuitable for the study
- •If the subject has had any other malignancies within the past year, other than basal or squamous cell carcinoma of the skin, diagnosis and location must be defined or be defined as clinically controlled or treated to complete response
研究组 & 干预措施
Previous ProstaScint®
Subjects with a previous 111-In capromab pendetide image of sufficient quality obtained within 60 days of study enrollment will receive 123-I-MIP-1072 alone.
干预措施: 123-I-MIP-1072 (Drug)
No Previous ProstaScint®
Subjects without a previous 111-In capromab pendetide image of sufficient quality obtained within 60 days of study enrollment will receive 123-I-MIP-1072 and 111-In capromab pendetide imaging.
干预措施: 123-I-MIP-1072 (Drug)
No Previous ProstaScint®
Subjects without a previous 111-In capromab pendetide image of sufficient quality obtained within 60 days of study enrollment will receive 123-I-MIP-1072 and 111-In capromab pendetide imaging.
干预措施: 111-In capromab pendetide (Drug)
结局指标
主要结局
Estimate the imaging sensitivity and specificity of 10.0 mCi or 5.0 mCi of 123I MIP 1072 compared to 5 mCi of 111In capromab pendetide in subjects with metastatic prostate cancer by determining the presence and extent of the disease.
时间窗: 24 hours post-injection
次要结局
- Examine the imaging sensitivity and specificity of 10.0 mCi or 5.0 mCi of 123I MIP 1072 compared to 5 mCi of 111In capromab pendetide on a per lesion basis in subjects with metastatic prostate cancer(Through 2 weeks post-injection)
- To describe the safety of administering 10.0 mCi and 5.0 mCi of 123I MIP 1072 for the detection of metastatic prostate cancer(Through 2 weeks post-injection)