A Phase 1 Pilot Comparison Study of 99mTc-MIP-1404 Single Photon Emission Computed Tomography (SPECT)/CT Imaging to Histology in Men With Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate
研究概览
简要总结
This is a single arm, open label study of up to 24 prostate cancer patients scheduled for prostatectomy and/or pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and/or pelvic lymph node dissection (PLND) within two weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male aged 21 years or older.
- •Ability to provide signed informed consent and willingness to comply with protocol requirements.
- •Past biopsy indicating the presence of adenocarcinoma of the prostate gland.
- •Participant is deemed to have tissue suspicious of prostate cancer involvement that is amenable to biopsy/resection.
- •Have had, or will undergo diagnostic CT or MRI imaging prior to surgery.
- •Participants must agree to use an acceptable form of birth control throughout the study period. Participants must use condoms for a period of seven days after study drug administration, if engaged in sexual activity.
排除标准
- •Participants for whom participating would significantly delay the scheduled standard of care therapy.
- •Participants administered a radioisotope within 5 physical half lives prior to study enrollment.
- •Participants with any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.
研究组 & 干预措施
Drug: 99mTc-MIP-1404
20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404
干预措施: 99mTc MIP 1404 (Drug)
结局指标
主要结局
Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate
时间窗: Within 3-6 hours of dosing SPECT/CT images will be taken
Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology) in patients undergoing standard of care prostatectomy
次要结局
- Safety of 99mTc-MIP-1404 will be assessed by measuring Vital Signs (blood pressure and heart rate)Pre-Dose and Post-Dose as well as between 3-6 hours post-dose(Vital signs measurements will be taken, an expected average of 30 minutes before and after study drug injection and between 3-6 hours after study drug injection)
- Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of pelvic lymph node(Within 3-6 hours of dosing SPECT/CT images will be taken)
- Intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression(PSMA expression analysis will be conducted upon completion of enrollment)