Preliminary Evaluation of Clinical Application of SPECT Imaging Targeting GPC3

January 19, 2026 updated by: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sPECT imaging targeting GPC3 in malignant tumors
Determine if targeting GPC3 SPECT is safe and effective method for imaging of malignant tumors.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation dose to human body
Time Frame: 1 year
Metric/method of measurement：Use OLINDA/EXM software
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Region of Interest,ROI
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • XLan-250923

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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