Malignant solid tumors
Conditions
Interventions
Gold Standard:Reference standard: PET/CT scan using 18F-FDG.
Index test:SUV values of PET/CT scan
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 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, or high imaging suspicion 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 laboratory values ?Blood routine examination (independent of transfusion or growth factor support within 14 days prior to signing the informed consent): Absolute neutrophil count = 1.0 × 10^9/L, Platelets=50*10^9/L, Hemoglobin =80g/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); Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase = 3 x ULN (AST, ALT, and alkaline phosphatase= 5 ×ULN if a patient has primary or metastatic liver cancer); Serum albumin = 30 g/L. ?Renal Function: Creatinine (Cr) =1.5×ULN; Creatinine Clearance (CCr) = 50 ml/min using the Cockcroft Gault formula. ?Coagulation function: International Normalized Ratio (INR), Prothrombin time (PT), activated partial thromboplastin time (aPTT)= 1.5 x ULN. If a patient is taking warfarin or heparin for anticoagulant therapy, it should be sure to meet protocol requirements when discontinuing or not taking the medication; 7)Women and men with childbearing age must agree to practice strict and effective contraception starting from signing informed consent to six months after the end of this study, during which time sperm donation is prohibited for men and egg freezing is prohibited for women. Negative serum pregnancy test for women of childbearing potential within 3 days prior to the first administration of the investigational drug.
Exclusion criteria
Exclusion criteria: 1)Patients with New York Heart Association (NYHA) class III-IV; 2)Patients with severe bleeding (e.g. gastrointestinal bleeding, intracranial bleeding) 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;safty; | — |
Secondary
| Measure | Time frame |
|---|---|
| Imageability; | — |
Countries
China
Contacts
Public ContactZhuzhong Cheng
Sichuan Cancer Hospital
Outcome results
None listed