First Human Trial of Targeting MDM2/MDMX PET Imaging

Inclusion criteria

• Ages 18 to 75 years, both males and females are eligible;
• Participants must meet the following criteria for blood routine and liver/kidney function tests: Complete blood count: WBC ≥ 4.0 × 10^9/L or neutrophils ≥ 1.5 × 10^9/L, platelets ≥ 100 × 10^9/L, hemoglobin ≥ 90 g/L; prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal (ULN); liver and kidney function: Total bilirubin ≤ 1.5 times the upper threshold limit (ULT), ALT/AST ≤ 2.5 ULN or ≤ 5 ULT for participants with liver metastasis, alkaline phosphatase (ALP) ≤ 2.5 ULN (if bone or liver metastases are present, ALP ≤ 4.5 ULN); Blood urea nitrogen (BUN) ≤ 1.5 × ULT, serum creatinine (SCr) ≤ 1.5 × ULT;
• Normal cardiac function;
• An expected survival of ≥ 12 weeks;
• Good follow-up compliance;
• According to RECIST 1.1 criteria, there must be at least one measurable target lesion;
• Women of childbearing age (15-49 years) must have a negative pregnancy test conducted within 7 days prior to enrollment; patients of childbearing potential must agree to use effective contraceptive methods to ensure they do not conceive during the study and for three months after examinations;
• Patients recommended for PET/CT evaluation for tumor diagnosis and staging by a clinician;
• Participants must fully understand the study and voluntarily participate, and must sign an informed consent form.

Exclusion criteria

• Severe abnormalities in liver and kidney function as well as hematological parameters;
• Patients who are planning a pregnancy;
• Pregnant or lactating women;
• Individuals unable to lie flat for thirty minutes;
• Individuals who refuse to participate in this clinical study;
• Individuals suffering from claustrophobia or other psychiatric disorders;
• Other conditions deemed by the researchers as unsuitable for participation in the trial.