Solid tumor
Conditions
Interventions
Case group:injection of 68Ga-FAP75
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 – 75 years (inclusive), male or female; 2. Pathologically confirmed solid tumor; 3. At least one lesion confirmed by conventional imaging; 4. ECOG (Eastern Cooperative Oncology Group) performance status: 0 or 1; 5. Major organ function meets the following requirements: a) Hemoglobin (Hb) >= 80 g/L; b) Platelet count >= 50 × 10?/L; c) Serum creatinine = 50 mL/min; 6. For women of childbearing potential, the pregnancy test result within 72 hours before the administration of the study drug must be negative, and they must agree to use non-hormonal contraceptive methods for at least 4 weeks after receiving the study drug. For men, they must agree to use contraceptive measures for at least 4 weeks after receiving the study drug; 1.Able to understand and comply with the procedures and requirements of this study, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Received the following treatments before administration: a) Received radiopharmaceuticals for diagnostic or therapeutic purposes before administration, with less than 10 physical half-lives elapsed since the last dose. b) Used any intravenously injected iodinated contrast medium within 24 hours before administration, or used any high-density oral contrast medium within 5 days before administration (oral aqueous contrast medium is acceptable). c) Received anti-tumor treatment (including but not limited to chemotherapy, radiotherapy, molecular targeted therapy, immunotherapy, etc.) within 14 days before administration. d) Enrolled within 12 weeks after the most recent surgical treatment; if the participant has recovered from the surgery before enrollment and meets other inclusion criteria, the time limit may be relaxed to 8 weeks at the investigator’s discretion (excluding non-therapeutic procedures such as needle biopsy). 2. Have the following concurrent diseases: a) Severe urinary incontinence, hydronephrosis, severe dysuria, etc. Note: For subjects with bladder outlet obstruction or urinary incontinence, if they can be controlled by the best available standard treatments (including incontinence pads, drainage, etc.), they are eligible to participate in the study. b) Have active infection or experience unexplained fever > 38.5°C for more than 1 hour during the screening period or before drug administration. c) Have severe or poorly controlled cardiac diseases or symptoms, including but not limited to: heart failure of NYHA class 2 or above, unstable angina pectoris, myocardial infarction occurred within 6 months before drug administration, QTcF > 450 msec in men or QTcF > 470 msec in women. d) Have severe or poorly controlled systemic diseases, including but not limited to poorly controlled diabetes, refractory hypertension, acute kidney injury, stroke, severe liver injury. e) Have active hepatitis B (for HBsAg-positive individuals, HBV-DNA needs to be detected, and HBV DNA >= 2000 IU/mL or 104 copies/mL), active hepatitis C (HCV-Ab positive and above the detection limit of the analytical method). f) Known to have acquired immunodeficiency syndrome (AIDS) or tested positive for human immunodeficiency virus (HIV). g) Have active syphilis infection. 3. Toxicities caused by previous anti-tumor treatment have not recovered to grade 90%), such as non-metastatic cutaneous basal cell carcinoma, cutaneous superficial squamous cell carcinoma, low-grade superficial bladder cancer, etc. 7. A history of definite severe neurological or psychiatric disorders. 8. Currently participating in another clinical study, or less than 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence and severity of adverse events (AEs);Organ and Tissue Absorbed Dose from Internal Irradiation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lesion uptake value SUVpeak;Lesion uptake value SUVmax;Maximum plasma concentration (Cmax)?Time to Maximum Concentration (Tmax);Cumulative Urinary Excretion Rate;Lesion uptake value SUVmean; | — |
Countries
China
Contacts
Public ContactXiaoli Lan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed