A Clinical Phase I/II Study Evaluating the Safety, Tolerability and Pharmacokinetics of the PSMA-targeted Fluorescent Contrast Agent DGPR1008 for Intraoperative Imaging in Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate the safety of single-dose administration of DGPR1008 in patients
研究概览
简要总结
a single-arm, open-label, multi-center study to evaluate safety, tolerability, pharmacokinetics, and the effectiveness of near-infrared fluorescence imaging during surgery.
详细描述
We plan to enroll 24 prostate cancer patients and divide them into 2 dosage groups. Intravenous administration will be conducted 24 hours before surgery. Blood samples will be collected for relevant tests, and fluorescence imaging will be performed during the operation. After surgery, the intraoperative imaging results will be compared with pathological findings to draw relevant conclusions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •Subjects must provide informed consent prior to enrollment, fully understand the trial details, adverse events, and communicate effectively with investigators. Written informed consent must be voluntarily signed.
- •Adult male subjects aged ≥18 years. Subjects with pathologically confirmed prostate cancer (Gleason score ≥7) via pre - operative prostate biopsy, scheduled for radical prostatectomy.
- •No significant liver or kidney impairment: liver - total bilirubin ≤2×ULN (except Gilbert syndrome), ALT/AST ≤3×ULN; kidney - creatinine clearance rate ≥50 mL/min/1.73m² (simplified MDRD).
- •No surgical contraindications; suitable for laparoscopic radical prostatectomy as determined by the investigator.
- •Subject and partner/spouse agree to avoid conception and sperm donation from screening until 3 months post - trial, and use effective contraception.
排除标准
- •Subjects will be excluded if any of the following apply:
- •Allergic constitution (history of allergy to ≥2 drugs), prone to allergic reactions, or allergic to the investigational drug (including components).
- •Clinically significant abnormal screening results affecting the study, or serious concomitant diseases (except stable cases approved by the investigator).
- •Participation in other clinical trials and received investigational products within 1 month before study drug administration.
- •Other conditions deemed unsuitable for enrollment by the investigator.
研究组 & 干预措施
The first dose group
Slowly infuse intravenously 24 hours before the scheduled surgery. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field.
干预措施: 0.02mg/kg (Drug)
The second dose group
Slowly infuse intravenously 24 hours before the scheduled surgery. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field.
干预措施: 0.04mg/kg (Drug)
结局指标
主要结局
To evaluate the safety of single-dose administration of DGPR1008 in patients
时间窗: From the screening period to the day before withdrawal on Day 3 of the trial
Physical examination, with body mass index (BMI) reported as weight (kg)/height (m²), electrocardiogram (ECG) examination, and laboratory tests (blood routine, blood biochemistry, urinalysis, coagulation function).
To evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients
时间窗: PK blood samples will be collected 60 minutes before drug administration, and immediately, 30 minutes (±5 minutes), 1 hour (±10 minutes), 2 hours (±10 minutes), 4 hours (±20 minutes), 6 hours (±30 minutes), and 8 hours (±30 minutes) after administration.
To measure the mean residence time (MRT₀-t, MRT₀-∞) of the drug in the blood of 24 subjects
次要结局
- Evaluate the effectiveness of the detection by DGPR1008 in conjunction with the near-infrared fluorescence imaging device for intraoperative imaging in patients.(24 hours before the surgery)
研究者
Haitao Niu, MD
Member of the Standing Committee of the Party Committee, Vice President of Qingdao University,
The Affiliated Hospital of Qingdao University