Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Phase
Not applicable
Started
2026-01-30
Last updated
2026-01-20
Condition(s) studied
HCCSPECT-CT
Investigational drug(s) / intervention(s)
131I-aGPC3
131I-aGPC3: 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
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. the subject or his/her legal representative can sign and date the informed consent form
2. commitment to follow the research procedures and cooperate in the implementation of the full-process research
3. patients with high clinical suspicion or histopathology diagnosis of HCC and generally in good condition
4. patients with a history of hepatocellular carcinoma who recur after treatment
5. 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:
1. inability to complete SPECTCT examination (including inability to lie down, claustrophobia, radiophobia, etc.)
2. acute systemic diseases and electrolyte disorders
3. patients with known hypersensitivity to GPC3 imaging agents or synthetic excipients
4. patients considered by the investigator to have poor adherence
5. pregnant or lactating patients
6. Have other factors not suitable to participate in this test
Primary outcome measure(s)
Radiation dose to human body — 1 year Metric/method of measurement：Use OLINDA/EXM software
Trial sites (1)
Facility
City
Region
Status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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