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NCT Number: NCT07727317

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

INR202+FDG

Diagnostic Test

single administration

Primary outcomes

  1. Number of detected lesions

    Time frame: From Day 1 to Day 10

Secondary outcomes

  1. Adverse events

    Time frame: From Day 3 to Day 7

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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