Evaluate the Diagnostic Efficacy and Safety of INR 202 PET/CT Imaging in Participants With Advanced Solid Tumors

NCT07727317 | Not Yet Recruiting

• 1 other identifier: INR202-IIT-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Number of detected lesions

  From Day 1 to Day 10

Secondary Outcomes (1)

• Adverse events

  From Day 3 to Day 7

Study Arms (1)

INR202+FDG

EXPERIMENTAL

All 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.

Diagnostic Test: INR202+FDG

Interventions

INR202+FDG DIAGNOSTIC_TEST

single administration

INR202+FDG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• ECOG performance status of 0 or 1.
• Advanced solid tumors.
• Adequate organ functions.
• Life expectancy ≥6 months.
• 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.
• 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.

You may not qualify if:

• Unable to complete imaging examinations as required by the study protocol, in the investigator's judgement.
• 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.
• Known hypersensitivity to the active ingredient of INR202 or any of its components.
• Any medical condition or other situation that, in the investigator's judgement, may affect safety, compliance, or study outcomes.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share