a single-arm, open-label, multi-center study to evaluate safety, tolerability, pharmacokinetics, and the effectiveness of near-infrared fluorescence imaging during surgery.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
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.
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
To evaluate the safety of single-dose administration of DGPR1008 in patients
Adverse event collection, including (such as the location, nature, and frequency of pain), physical signs (such as the scope of rash, blood pressure values), laboratory abnormal values and units (such as ALT 200 U/L), etc.
Time frame: From the screening period to the day before withdrawal on Day 3 of the trial
To evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients
To measure the area under the plasma concentration-time curve from time 0 to infinity (AUC₀-∞) in the blood of 24 subjects
Time frame: 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 evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients
To measure the maximum plasma concentration (Cmax) in the blood of 24 subjects
Time frame: 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 evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients
To measure the area under the plasma concentration-time curve from time 0 to time t (AUC₀-t) in the blood of 24 subjects
Time frame: 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 evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients
To measure the percentage of extrapolated area under the plasma concentration-time curve (AUC%Extrap) in the blood of 24 subjects
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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 evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients
To measure the plasma elimination half-life (t₁/₂) in 24 subjects
Time frame: 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 evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients
To measure the blood clearance (CL) in 24 subjects
Time frame: 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 evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients
To measure the renal clearance (CL renal) in 24 subjects
Time frame: 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 evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients
To measure the terminal elimination rate constant (λz) in 24 subjects
Time frame: 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 evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients
To measure the apparent volume of distribution during terminal phase (Vz) in 24 subjects
Time frame: 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 evaluate the safety of single-dose administration of DGPR1008 in patients
Vital signs examination, such as blood pressure, oxygen saturation, pulse and other data.
Time frame: From the screening period to the day before withdrawal on Day 3 of the trial
To evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients
To measure the mean residence time (MRT₀-t, MRT₀-∞) of the drug in the blood of 24 subjects
Time frame: 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 evaluate the safety of single-dose administration of DGPR1008 in patients
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).
Time frame: From the screening period to the day before withdrawal on Day 3 of the trial
Evaluate the effectiveness of the detection by DGPR1008 in conjunction with the near-infrared fluorescence imaging device for intraoperative imaging in patients.
Evaluate the sensitivity, specificity, false positive rate, false negative rate of DGPR1008 in detecting prostate cancer cells or tissues in near-infrared imaging, and assess the tumor-to-background ratio.
Time frame: 24 hours before the surgery