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NCT07727317
Evaluate the Diagnostic Efficacy and Safety of INR 202 PET/CT Imaging in Participants With Advanced Solid Tumors
Conditions: Solid Tumors
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Shanghai Zhongshan Hospital
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07727317). StuddyBuddy aggregates publicly available trial information.