The primary objective of this study is: to evaluate the safety of technetium \[99mTc\]-H7ND injection in patients with gastrointestinal malignancies and in healthy subjects. The secondary objectives of this study are: (1) to examine the pharmacokinetics of technetium \[99mTc\]-H7ND Injection in healthy subjects. (2) Detect the metabolic stability of technetium \[99mTc\]-H7ND injection in healthy humans. (3) Detect the biodistribution and estimate the absorbed dose of radiation from internal irradiation of technetium \[99mTc\]-H7ND injection in patients with malignant tumors of the gastrointestinal tract and in healthy humans.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
24
Technetium \[99mTc\]-H7ND injection is a radiolabeled fibroblast activation protein inhibitor
Zhongshan Hospital Affiliated to Fudan University
Shanghai, China
Security Indicators
Evaluation of adverse events and serious adverse events according to the Common Terminology Criteria for the Evaluation of Adverse Events (NCI-CTCAE) version 5.0
Time frame: 1-7 days from time of injection
uptake value ratio
Measure the count ratio of technetium \[99mTc\]-H7ND tumor area to blood pool, surrounding normal tissue, liver, and muscle in the integrated region of interest.
Time frame: 3 days after injection
biodiversity distribution
SPECT/CT whole-body scans were performed at different time points after drug injection to obtain radioactivity counts (%ID) in each major irradiated organ at each time phase to reflect the biodistribution of the drug in the body
Time frame: 3 days after injection
internal radiation dose
Plot the "time-activity count" curve for each major organ and calculate the area under the curve. Calculate the retention time of each major exposed organ and apply the software to estimate the absorbed dose of internal radiation for each major exposed organ.
Time frame: 3 days after injection
Concentration of technetium [99mTc] H7ND prototype and its radioactive metabolites
Blood samples were collected at different time points after drug injection, and urine samples were collected at different time intervals for detection of technetium \[99mTc\] H7ND prototype and its radioactive metabolites using either a radioactive HPLC detector or a radioactive TLC detector.
Time frame: Predose and up to 72 hours postdose
Pharmacokinetic parameters
Cmax
Time frame: Predose and up to 72 hours postdose
Pharmacokinetic parameters
AUC(0-t)
Time frame: Predose and up to 72 hours postdose
Pharmacokinetic parameters
AUC(0-∞)
Time frame: Predose and up to 72 hours postdose
Pharmacokinetic parameters
Tmax
Time frame: Predose and up to 72 hours postdose
Pharmacokinetic parameters
T1/2
Time frame: Predose and up to 72 hours postdose
Pharmacokinetic parameters
AUC\_%Extrap
Time frame: Predose and up to 72 hours postdose
Pharmacokinetic parameters
CL
Time frame: Predose and up to 72 hours postdose
Pharmacokinetic parameters
Vd
Time frame: Predose and up to 72 hours postdose
Pharmacokinetic parameters
MRT
Time frame: Predose and up to 72 hours postdose
Pharmacokinetic parameters
λz
Time frame: Predose and up to 72 hours postdose
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