Evaluate the Diagnostic Efficacy and Safety of INR 202 PET/CT Imaging in Participants With Advanced Solid Tumors
- Sponsor
- Shanghai Zhongshan Hospital
- Study ID
- NCT07727317
- Status
- Not Yet Recruiting
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Conditions
- Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- INR202+FDG — DIAGNOSTIC_TESTsingle administration
Study Details
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.
Key Dates
- First listed
- Jul 27, 2026
- Start date
- Aug 31, 2026
- Status verified
- Jul 2026
- Primary completion
- Jul 31, 2028
- Completion
- Jul 31, 2028
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: INR202+FDGAll eligible participants will receive a single administration of INR202 injection. A PET/CT scan will be performed post-dose. All subjects will undergo a follow-up visit during the safety follow-up period. Subsequently, subjects will undergo 18F-FDG PET/CT imaging.
Primary Outcome Measure
Number of detected lesions [ Time Frame: From Day 1 to Day 10 ]
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