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NCT Number: NCT07353333

Preliminary Evaluation of Clinical Application of SPECT Imaging Targeting GPC3

This project will target patients with highly clinically suspected or histopathology diagnosed hepatocellular carcinoma (HCC) using targeted GPC3-specific imaging agents (e.g. , Iodine-131-aGPC3-Scfv) for integrated SPECTCT imaging, to evaluate the pharmacokinetics distribution of the targeted drug in patients with hepatocellular carcinoma (HCC) by low-dose integrated diagnosis and treatment (i.e. , Iodine-131-RRB- imaging, to determine the metabolism, safety and tolerability of the drug in vivo Secondary objective: to evaluate the targeting of GPC3-SPECIFIC imaging agents in patients with hepatocellular carcinoma to assess the feasibility of this targeted agent for future treatment.

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Key information

Conditions

HCC SPECT-CT

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • the subject or his/her legal representative can sign and date the informed consent form
  • commitment to follow the research procedures and cooperate in the implementation of the full-process research
  • patients with high clinical suspicion or histopathology diagnosis of HCC and generally in good condition
  • patients with a history of hepatocellular carcinoma who recur after treatment
  • women in their reproductive years were using contraception for at least one month before screening and were committed to using contraception throughout the study period and for the prescribed period after the end of the study

Exclusion criteria

  • inability to complete SPECTCT examination (including inability to lie down, claustrophobia, radiophobia, etc.)
  • acute systemic diseases and electrolyte disorders
  • patients with known hypersensitivity to GPC3 imaging agents or synthetic excipients
  • patients considered by the investigator to have poor adherence
  • pregnant or lactating patients
  • Have other factors not suitable to participate in this test

Treatment and study plan

131I-aGPC3

Drug

Using targeted GPC3-specific imaging agents (e.g. , Iodine-131-aGPC3-Scfv) for integrated SPECTCT imaging, evaluate the pharmacokinetics distribution of the targeted drug in patients with hepatocellular carcinoma (HCC) by low-dose integrated diagnosis and treatment (i.e. , Iodine-131- imaging), and determine the metabolism, safety and tolerability of the drug in vivo

Primary outcomes

  1. Radiation dose to human body

    Time frame: 1 year

    Metric/method of measurement：Use OLINDA/EXM software

Secondary outcomes

  1. Region of Interest,ROI

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoli Lan, Xiaoli Lan

CONTACT

[email protected]

0086-027-83692633

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 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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