The purpose of this study is to develop and clinically evaluate 89Zr-labeled HER2-targeted antibody fragments in diagnosis and screening of HER2-positive cancer patients.
The following is a detailed description of the objectives of the study: Main objectives: * Application of novel radionuclide-labeled HER2-targeting molecular probes (89Zr-LNCab103 and 89Zr-LNCab104) in the early diagnosis of breast cancer, gastric cancer, urothelial carcinoma and other diseases; * To evaluate the efficacy, safety and dosimetry of 89Zr-LNCab103 and 89Zr-LNCab104 in clinical PET imaging applications. Secondary Objectives: * To investigate the biodistribution of 89Zr-LNCab103 and 89Zr-LNCab104 in patients with breast cancer, gastric cancer and urothelial carcinoma, including the distribution of primary and metastatic tumors and normal tissues, through the evaluation of whole-body imaging and SUV values using PET/CT imaging. * Compared with 18F-FDG, the clinical application value and diagnostic advantages of the novel radionuclide-labeled HER2-targeting molecular probes 89Zr-LNCab103 and 89Zr-LNCab104 were evaluated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
89Zr-LNCab104 is administered through a superficial dorsal vein, and the patient is given a dose of about 1-3 mCi
89Zr-LNCab103 is administered through a superficial dorsal vein, and the patient is given a dose of about 1-3 mCi
18F-FDG is administered through a superficial dorsal vein, and the patient is given a dose of about 0.1-0.15mCi/kg.
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
Tumor Uptake Value (SUVmax) of HER2-Targeted PET/CT Compared with 18F-FDG PET/CT
The maximum standardized uptake value (SUVmax) of identified lesions on HER2-targeted PET/CT using 89Zr-LNCab103 and 89Zr-LNCab104 will be measured and compared with the SUVmax of lesions detected on 18F-FDG PET/CT imaging in the same patients. Units of Measure: SUVmax (unitless)
Time frame: Day 1 post-injection
Number of Lesions Detected by HER2-Targeted PET/CT Compared with 18F-FDG PET/CT
The number of lesions detected by HER2-targeted PET/CT using 89Zr-labeled antibodies will be recorded and compared to the number of lesions detected by 18F-FDG PET/CT imaging in the same patient population. Units of Measure: Number of lesions
Time frame: Day 1 post-injection
Biodistribution of 89Zr-Labeled HER2-Targeted Antibodies in Normal Organs
The biodistribution of 89Zr-LNCab103 and 89Zr-LNCab104 will be evaluated by measuring the mean standardized uptake values (SUVmean) in various normal organs (e.g., liver, kidney, lung, spleen, bone marrow) during HER2-targeted PET/CT imaging. Units of Measure: SUVmean (unitless)
Time frame: Day 1 post-injection
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