Malignant tumor
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) The subject voluntarily participates in the trial and signs the informed consent form; (2) Age = 18 years old and = 80 years old (subject to the date of signing the informed consent form), gender is not limited; (3) Patients with malignant solid tumors with high suspicion of imaging or histological/cytology confirmed by histological/cytology, and patients who are going to undergo surgery; (4) The physical status score (ECOGPS) of the Eastern Cancer Cooperative Group was 0-1 points; (5) Estimated survival time = 6 months; (6) Female subjects of childbearing age, male subjects, and partners of male subjects agree to use reliable contraceptive measures (e.g., abstinence, sterilization, birth control pills, injectable contraceptives methylprogesterone, or subcutaneous contraception) for 6 months after the end of the last study drug infusion.
Exclusion criteria
Exclusion criteria: (1) Known allergy to injection or its excipients; (2) Those who have received any investigational drug or device clinical trial within 30 days (or 5 half-lives of the drug, whichever is longer) before signing the ICF; (3) Female patients who plan to become pregnant within 6 months, or are pregnant or breastfeeding; (4) claustrophobia; (5) Those who cannot tolerate raising their arms and lying flat for 15~30min; (6) Other circumstances that the investigator believes should be excluded and documented.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;positive predictive value;negative predictive value; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Standard Uptake Value;Mean Standard Uptake Value;Maximum tumor-to-background ratio;Mean tumor-to-background ratio,TBR;total lesion uptake,TLU; | — |
Countries
China
Contacts
Zhongnan Hospital of Wuhan University