A Phase 1 Pilot Study of 99mTc-MIP-1404 Single Photon Emission Computed Tomography (SPECT)/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection (PLND)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Tissue distribution of 20 (± 3) mCi 99mTc-MIP-1404
研究概览
简要总结
This is a single arm, open label study of up to 24 high risk 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. Patients may receive a second injection of study drug within 24 hours of surgery to measure activity counts in tissue samples post-surgery, but prior to pathology processing. 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 be high-risk with potential for pelvic lymph node involvement. The criteria for high-risk are:
- •Patient has PSA value >10 and clinical stage T2 or higher, and Gleason score 8, 9 or
- •Patient has PSA value >20 and clinical stage T2 or higher, and Gleason score
- •Participant is or will be scheduled to undergo standard of care prostatectomy and/or pelvic lymph node dissection.
- •Have had (within previous 2 months) or will undergo diagnostic CT or MRI imaging prior to surgery.
- •Have had (within previous 2 months) or will undergo bone scan 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 each injection, 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
20 (±3) mCi of study drug
干预措施: 99mTc-MIP-1404 (Drug)
结局指标
主要结局
Tissue distribution of 20 (± 3) mCi 99mTc-MIP-1404
时间窗: Post-procedure
99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
次要结局
- Safety of 99mTc-MIP-1404: Change in Vital Signs from Pre-Dose to Post-Dose(Vital signs measurements will be measured, an expected average of 30 minutes before and after study drug injection)
- Intensity of 99mTc-MIP-1404 Uptake with Respect to PSMA expression(Post-procedure)
- Safety of 99mTc-MIP-1404: Summary of Treatment-Emergent Adverse Events (TEAEs)(Adverse events will be assessed for the duration of the study participation, an expected average of 3 weeks)