clinical study on pet imaging, distribution and pk of 89zr-cd147 in patients with solid tumors

Conditions: Solid Tumor

Summary: the primary objective of this study is to observe the distribution of 89zr-cd147 and radiation dosimetry characteristics in patients with solid tumors. the secondary objective is to observe the pharmacokinetic characteristics of 89zr-cd147 in patients with solid tumors. this study is a single-center, open-lable study, including 89zr-cd147 1mci±10%，89zr-cd147 3mci±10% and 89zr-cd147 5mci±10% dose group. the trial is expected to last for 2 years from the first patient signing the consent form to the end of the trial.

antibody based positron emission tomography (immuno-pet) imaging is of increasing importance to visualize and characterize tumor lesions. additionally, it can be used to identify patients who may benefit from a particular therapy and monitor the therapy outcome.

Eligibility criteria:
inclusion criteria: 1. patients must be between 18 and 70 years old (including 18 and 70 years old), male or female; 2. patients with advanced solid tumors (stage iv): non-small cell lung cancer (nsclc); gastric adenocarcinoma; colorectal adenocarcinoma, etc ; 3. patients must have an ecog performance status of 0-1; 4. patients must have a life expectancy ≥ 12 weeks; 5. patients must have adequate organ function: white blood cell (wbc) count≥4.0x10\^9/l or absolute neutrophil count (anc) ≥1.5 x 10\^9/l, platelets ≥100 x 10\^9/l, hemoglobin≥ 90g/l ; thrombin time or activated partial thromboplastin time≤1.5uln; liver and renal function: total bilirubin≤1.5uln (upper limit of normal), alanine aminotransferase (alt) or aspartate aminotransferase (ast)≤2.5uln or ≤5uln (subjects with liver metastasis), alkaline phosphatase (alp)≤ 2.5uln (if there is bone metastasis or liver metastasis alp≤4.5uln). urea (bun)≤1.5uln, creatinine≤1.5uln; 6. patients must have ≥1 measurable lesion according to recist1.1 criteria; 7. for patients who have partners of childbearing potential: partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principle investigator during the study and for 6 months after last study drug administration.; 8. patients must have the ability to understand and sign an approved icf. exclusion criteria: 1. there are any of the following conditions, such as brain metastasis (except for asymptomatic primary or metastatic brain tumors that do not need treatment), carcinomatous meningitis, myocardial infarction (within 6 months before enrollment), unstable angina pectoris, or high risk of uncontrollable arrhythmia, coronary artery bypass grafting, cerebrovascular accident (within 6 months before enrollment), congestive heart failure (cardiac function grade iii-iv), pulmonary embolism, deep venous thrombosis, infections that need to be treated with intravenous antibiotics within 2 weeks, and immunosuppressant therapy after organ transplantation; 2. primary central nervous system tumor; 3. hbv dna≥1000 copies/ml; 4. hcv-rna≥1000 copies/ml; 5. people with positive antibodies to hiv or syphilis; 6. patients with acute or subacute intestinal obstruction, or a history of inflammatory bowel disease; 7. women who are pregnant, breastfeeding or planning pregnancy; 8. people who are known to be allergic to the study preparation or its auxiliary materials; 9. people with a history of psychotropic substance abuse and inability to get rid of it or mental disorders; 10. patients who cannot lie for half an hour; 11. patients who are allergic to any component of the imaging agent or antibody; 12. patients who cannot accept pet/ct imaging; 13. situations that other researchers consider unsuitable to participate in the trial.