Preliminary Evaluation of Clinical Application of SPECT Imaging Targeting GPC3
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 131I-aGPC3.
- Who it may be relevant to
- Registry conditions: HCC, SPECT-CT. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug 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
Primary outcome measures
- Radiation dose to human body [Time frame: 1 year]
Secondary outcome measures (1)
- Region of Interest,ROI [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT07353333 · XLan-250923