Preliminary Evaluation of Clinical Application of SPECT Imaging Targeting GPC3

NCT07353333 | Not Yet Recruiting

• 1 other identifier: XLan-250923
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HCC; SPECT-CT

Outcome Measures

Primary Outcomes (1)

• Radiation dose to human body

  Metric/method of measurement：Use OLINDA/EXM software

  1 year

Secondary Outcomes (1)

• Region of Interest,ROI

  1 year

Study Arms (1)

sPECT imaging targeting GPC3 in malignant tumors

EXPERIMENTAL

Determine if targeting GPC3 SPECT is safe and effective method for imaging of malignant tumors.

Drug: 131I-aGPC3

Interventions

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

sPECT imaging targeting GPC3 in malignant tumors

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

Central Study Contacts

Xiaoli Lan, Xiaoli Lan

CONTACT

0086-027-83692633; lxl730724@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 20, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)