Solid Tumors
Conditions
Brief summary
This is a prospective, single-center, open-label clinical study comparing the imaging performance of INR202 PET/CT versus 18F-FDG PET/CT in participants with advanced solid tumors.
Interventions
DIAGNOSTIC_TESTINR202+FDG
single administration
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years. 2. ECOG performance status of 0 or 1. 3. Advanced solid tumors. 4. Adequate organ functions. 5. Life expectancy ≥6 months. 6. Agreement to use contraceptive measures from the date of informed consent signing until 3 months after administration of INR202, and to avoid sperm or egg donation during this period. 7. The participant (or legal guardian, where applicable) is fully informed of the purpose and procedures of the study, is able to understand the information provided, and voluntarily signs the informed consent form.
Exclusion criteria
1. Unable to complete imaging examinations as required by the study protocol, in the investigator's judgement. 2. With a history of ≥2 malignancies within 5 years prior to administration of INR202, except for adequately treated non-metastatic thyroid cancer, basal cell carcinoma of the skin, superficial squamous cell carcinoma of the skin, or superficial bladder cancer. 3. Known hypersensitivity to the active ingredient of INR202 or any of its components. 4. Any medical condition or other situation that, in the investigator's judgement, may affect safety, compliance, or study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of detected lesions | From Day 1 to Day 10 |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | From Day 3 to Day 7 |
Outcome results
None listed