Malignant solid tumors
Conditions
Interventions
Test group1:Doses: 0.05 mg/kg
Administration route: Intravenous injection
Method of administration: Infuse 100 ml of the SA-FCA mixed solution intravenously over 60 minutes. During the infusion, the
Test group2:Doses: 0.10 mg/kg
Administration route: Intravenous injection
Method of administration: Infuse 100 ml of the SA-FCA mixed solution intravenously over 60 minutes. During the infusion, th
Test group3:Doses: 0.20 mg/kg
Administration route: Intravenous injection
Method of administration: Infuse 100 ml of the SA-FCA mixed solution intravenously over 60 minutes. During the infusion, th
Test group4:Doses: 0.40 mg/kg
Administration route: Intravenous injection
Method of administration: Infuse 100 ml of the SA-FCA mixed solution intravenously over 60 minutes. During the infusion, the
Test group5:Doses: 0.60 mg/kg
Administration route: Intravenous injection
Method of administration: Infuse 100 ml of the SA-FCA mixed solution intravenously over 60 minutes. During the infusion, th
Sponsors
Lishui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Must provide informed consent prior to the trial, fully understand the study content, procedures, and potential adverse reactions, be able to communicate effectively with the researchers, and be able to complete the trial according to the protocol, and voluntarily sign a written informed consent form; 2. Any gender patients 18 years of age and older; 3. Diagnosed with malignant solid tumors clinically or pathologically before surgery, scheduled for radical surgery or lymph node dissection, including newly diagnosed and recurrent patients; 4. No liver and kidney impairment: Total bilirubin = 50 mL/min; 5. No contraindications for surgery as judged by the researcher, suitable for laparoscopic radical tumor surgery; 6. Agree to no plans for childbirth or sperm donation from screening to 3 months post-study and voluntarily take effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution (known allergy to two or more drugs), or prone to allergic symptoms such as rash, urticaria, or patients known to any component of the trial medication; 2. Liver or kidney impairment; 3. Current non-infectious pneumonia or symptoms indicative of it; 4. Clinically significant abnormalities in physical exams, vital signs, lab tests, or 12-lead ECG, etc. (including but not limited) as judged by the researchers; 5. History of allergic reactions due to compounds with similar chemical or biological components as those used in the study; 6. History of severe neurological or psychiatric disorders, including epilepsy or dementia; 7. Active severe autoimmune diseases, acquired or congenital immunodeficiency, HIV positive, or history of organ transplantation; 8. Participation in another clinical trial within the last month and receipt of trial medication or devices; 9. Accompanying diseases that seriously endanger patient safety or affect study completion, or other conditions deemed unsuitable by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compared with white light endoscope, the proportion of patients using SA-FCA combined with fluorescence endoscope to detect one or more additional malignant lesions;Adverse events (AE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor-to-background ratio (TBR);Diagnostic effectiveness:Sensitivity; Specificity/false positive rate; Positive predictive value (PPV);Pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactJiansong Ji
Lishui Central Hospital
Outcome results
None listed