Malignant Solid Tumors
Conditions
Interventions
Experimental group:68Ga-NRT6020 injection
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Willingness and ability to participate in this clinical study and sign informed consent before any study procedures are implemented. 2. Age =18 years. 3. Life expectancy of more than 3 months. 4. Pathological diagnosis of malignant solid tumors. 5. Have an Eastern Oncology Group (ECOG) performance status of 0 or 1. 6. Have adequate organ function confirmed by the following tests: ?Blood routine examination (independent of transfusion or growth factor support within 14 days prior to signing the informed consent): absolute neutrophil count =1000 cells/mm3, platelet count =50000/mm3, hemoglobin =80 g/L. ?Hepatic Function: Total Bilirubin (TBIL) = 1.5 x upper limit of normal (ULN) (TBIL = 2 x ULN is acceptable if a patient has primary or metastatic liver cancer); alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase =3 ×ULN (=5×ULN for primary or metastatic liver cancer); Serum albumin >30 g/L. ?Renal Function: creatinine (Cr) =1.5×ULN; creatinine clearance (CCr) =50 mL/min (calculated using Cockcroft-Gault formula). ?Coagulation function: international normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (APTT) =1.5×ULN. If the subject is on warfarin or heparin anticoagulation therapy, it must be ensured that the protocol requirements are met when the medication is stopped or not used. ?Cardiovascular function: echocardiography: left ventricular ejection fraction (LVEF) =50%. 7. Women and men of childbearing potential must agree to practice strict and effective contraceptive measures after signing the informed consent, during the study, and for 6 months after the end of the trial. Men are prohibited from donating sperm, and women are prohibited from freezing eggs during this period. Women of childbearing potential must have a negative pregnancy test result within 3 days before the first administration.
Exclusion criteria
Exclusion criteria: 1. Patients with New York Heart Association (NYHA) class III-IV. 2. Severe bleeding (e.g., gastrointestinal bleeding, intracranial hemorrhage) within 6 months prior to administration of the investigational drug. 3. Known severe allergy to components of the investigational drug or its analogues. 4. Patient has undergone surgery involving general anesthesia and major incisions (larger than the incision required for central venous access, percutaneous feeding tube, or biopsy) performed within 28 days before signing informed consent. 5. Patients with two or more malignant tumors at the same time. 6. Patients with bacterial, viral or fungal infections that require systemic treatment. 7. Patients with actively treated but still uncontrolled and stable disease that the investigator determines may affect the safety or efficacy of the investigational drug. 8. Patients who have participated in any other interventional clinical trial within 3 months prior to screening (except patients who have only participated in the screening of clinical trials and have not used the experimental drug). 9. Known pregnant or lactating women. 10. Any other situations that the investigator determines are not suitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Imaging Performance; | — |
Countries
China
Contacts
Public ContactRong Tian
West China Hospital, Sichuan University
Outcome results
None listed