Clinical Study on PET Imaging, Distribution and PK of 89Zr-CD147 in Patients With Solid Tumors

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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.

Official Title
-----------------
Clinical Study on Positron Emission Tomography (PET) Imaging, Distribution and Pharmacokinetics of 89 Zirconium (Zr)-CD147 in Patients With Solid Tumors

Conditions
-----------------
Solid Tumor

Intervention / Treatment
-----------------
* Drug: 89Zr-CD147


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be between 18 and 70 years old (including 18 and 70 years old), male or female; Patients with advanced solid tumors (stage IV): non-small cell lung cancer (NSCLC); Gastric adenocarcinoma; Colorectal adenocarcinoma, etc ; Patients must have an ECOG performance status of 0-1; Patients must have a life expectancy ≥ 12 weeks; 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; Patients must have ≥1 measurable lesion according to RECIST1.1 criteria; 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.; Patients must have the ability to understand and sign an approved ICF. Exclusion Criteria: 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; Primary central nervous system tumor; HBV DNA≥1000 copies/ml; HCV-RNA≥1000 copies/ml; People with positive antibodies to HIV or syphilis; Patients with acute or subacute intestinal obstruction, or a history of inflammatory bowel disease; Women who are pregnant, breastfeeding or planning pregnancy; People who are known to be allergic to the study preparation or its auxiliary materials; People with a history of psychotropic substance abuse and inability to get rid of it or mental disorders; Patients who cannot lie for half an hour; Patients who are allergic to any component of the imaging agent or antibody; Patients who cannot accept PET/CT imaging; Situations that other researchers consider unsuitable to participate in the trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 89Zr-CD147 1mCi±10% 10mg dose group<br>The activity administered was 1mCi±10% and the mass of radiolabeled CD147 was 10 mg. | Drug: 89Zr-CD147<br>* The 89Zr-CD147 is a promising positron emission tomography probe and it is possible to select suitable tumor patients with CD147 expression to benefit from anti-CD147 treatment.<br>|
| Experimental: 89Zr-CD147 3mCi±10% 10mg dose group<br>The activity administered was 3mCi±10% and the mass of radiolabeled CD147 was 10 mg. | Drug: 89Zr-CD147<br>* The 89Zr-CD147 is a promising positron emission tomography probe and it is possible to select suitable tumor patients with CD147 expression to benefit from anti-CD147 treatment.<br>|
| Experimental: 89Zr-CD147 5mCi±10% 10mg dose group<br>The activity administered was 5mCi±10% and the mass of radiolabeled CD147 was 10 mg. | Drug: 89Zr-CD147<br>* The 89Zr-CD147 is a promising positron emission tomography probe and it is possible to select suitable tumor patients with CD147 expression to benefit from anti-CD147 treatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized uptake value (SUV) | Standardized uptake value of tumor | Day 0-7 | 
| standardized uptake value ratio (SUVR) | The ratio of the standardized uptake value of the tumor or suspected tumor lesion to the standardized uptake value of normal tissue | Day 0-7 | 
| Radiation dose | Radiation dose of whole body and major tissues / organs of subjects after administration | Day 0-7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Terminal Half Time (T1/2) | Pharmacokinetic parameters | Day 0-7 | 
| Clearance (CL) | Pharmacokinetic parameters | Day 0-7 | 
| Peak Plasma Concentration (Cmax) | Pharmacokinetic parameters | Day 0-7 | 
| Area under the plasma concentration versus time curve (AUC) | Pharmacokinetic parameters | Day 0-7 | 
| Distribution (dL) | Pharmacokinetic parameters | Day 0-7 |