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Not yet recruitingNCT07353333Updated Jan 20, 2026

Preliminary Evaluation of Clinical Application of SPECT Imaging Targeting GPC3

An interventional study of 131I-aGPC3 in HCC and SPECT-CT, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

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.

02

Conditions studied

  • HCC
  • SPECT-CT
03

In context

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 160 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (estimated)

Study arms

  • 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

Interventions

  • Drug131I-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

06

What researchers measure

Primary outcomes

  1. Radiation dose to human body

    Metric/method of measurement:Use OLINDA/EXM software

    Time frame: 1 year

Secondary outcomes

  1. Region of Interest,ROI

    Time frame: 1 year

07

Study locations

1 site
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430030, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07353333
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Responsible party
Sponsor
First posted
Jan 20, 2026
Start date
Jan 30, 2026 (estimated)
Primary completion
Aug 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Jan 20, 2026

Study contacts

Xiaoli Lan, Xiaoli Lan
Contact
lxl730724@hotmail.com
0086-027-83692633

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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