Molecular Phenotyping and Image-Guided Surgical Treatment of Prostate Cancer Using Ultrasmall Silica Nanoparticles
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Side effects
研究概览
简要总结
The purpose of this study is to see whether using the copper-64 (64Cu) or zirconium-89 (89Zr) radiolabeled PSMA-targeting C' dot tracer, termed 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots or 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots, is a safe way to identify tumor cells before and during surgery for prostate cancer. The researchers want to determine whether pre-operative PET/MRI scans and intra-operative optical imaging performed in prostate cancer patients after the injection of one of these investigational tracers more accurately localizes cancerous deposits within the surgical bed as compared with conventional imaging scans alone. The researchers will study how the tracer travels through your body and where it is distributed. This study is the first time that the tracer will be used in patients undergoing surgery for prostate cancer.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Primary RP + PLND
- •Age ≥18 years
- •Patients meeting one of the following criteria:
- •Tumor clinical stage T3a or higher
- •Gleason score 8-10, or
- •PSA level > 20 ng/mL
- •Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion
- •Patient is scheduled for standard of care laparoscopic radical prostatectomy (with or without robotic assistance)
- •Salvage PLND
- •Age ≥18 years
- •Patients with presence of suspicious lymph node on CT or MRI (of a pelvic node => 10mm in short axis or a node with abnormal morphology such as roundness irregularity or loss of fatty hilum, or PSMA-avid on PSMA PET imaging
- •Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion
- •Patient is scheduled for standard of care salvage pelvic lymph node dissection (with or without robotic assistance)
排除标准
- •Contraindications to standard-of-care MR imaging (e.g., metal implants, claustrophobia)
- •Prior androgen-deprivation therapy for prostate cancer (N/A for Salvage PLND)
- •Prior pelvic radiotherapy (N/A for Salvage PLND )
- •Medical illness unrelated to the tumor that, in the opinion of the attending physician and principal investigator, will preclude administration of the tracer
- •°This includes patients with uncontrolled infection, chronic renal insufficiency (EGFR < 60 mL/min/1.73m2), myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease
- •Weight greater than the 400-lb weight limit of the PET scanner
- •Unmanageable claustrophobia
- •Inability to lie in the scanner for 30 min
研究组 & 干预措施
Prostate cancer patients
Patients will receive an intravenous (IV) injection of approximately 6-7 mCi (+/- 10%) of PSMA-targeting C' dot tracer up to 48 h before surgery. Patients will then undergo serial preoperative PET/MR imaging (see below) to help characterize the safety, biodistribution/pharmacokinetics, and dosimetry of this agent. To assess total radioactivity in whole blood/plasma and urine samples, as well as radioactive metabolites, blood and urine samples will be collected at approximately 30 min post-injection as well as before each imaging session.
干预措施: PET/MRI/fluorescence imaging (Diagnostic Test)
Prostate cancer patients
Patients will receive an intravenous (IV) injection of approximately 6-7 mCi (+/- 10%) of PSMA-targeting C' dot tracer up to 48 h before surgery. Patients will then undergo serial preoperative PET/MR imaging (see below) to help characterize the safety, biodistribution/pharmacokinetics, and dosimetry of this agent. To assess total radioactivity in whole blood/plasma and urine samples, as well as radioactive metabolites, blood and urine samples will be collected at approximately 30 min post-injection as well as before each imaging session.
干预措施: Blood and urine sampling (Other)
Prostate cancer patients
Patients will receive an intravenous (IV) injection of approximately 6-7 mCi (+/- 10%) of PSMA-targeting C' dot tracer up to 48 h before surgery. Patients will then undergo serial preoperative PET/MR imaging (see below) to help characterize the safety, biodistribution/pharmacokinetics, and dosimetry of this agent. To assess total radioactivity in whole blood/plasma and urine samples, as well as radioactive metabolites, blood and urine samples will be collected at approximately 30 min post-injection as well as before each imaging session.
干预措施: laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection (Procedure)
结局指标
主要结局
Side effects
时间窗: 1 year
Will be described using CTCAE version 5 criteria.
次要结局
未报告次要终点