GPC3-Targeted PET Imaging of 18F-X12 in Hepatocellular Carcinoma

August 29, 2026 updated by: Meng LIU, Peking University First Hospital

Clinical Study of Glypican-3 (GPC3)-Targeted Novel Probe 18F-X12 for the Diagnosis of Hepatocellular Carcinoma (HCC)

This is a diagnostic study. This clinical trial aims to evaluate the diagnostic performance and safety of the novel radiotracer 18F-X12 in patients with hepatocellular carcinoma (HCC), and to provide evidence supporting a new approach for its early diagnosis, accurate staging and recurrence assessment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

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
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, Municipality 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Peking University First Hospital
          • Phone Number: +86 010-83576401
          • Email: bdyyll@126.com

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

Yes

Description

Inclusion Criteria:

  • Patients aged ≥ 18 years old.
  • Patients fully understand the trial requirements, participate in the study voluntarily, and provide written informed consent.
  • Meet either of the following two conditions:
  • Patients with highly suspected hepatocellular carcinoma (HCC) (hepatic space-occupying lesion of undetermined nature on imaging examination) or pathologically confirmed HCC, with no prior systemic therapy (including immunotherapy, chemoradiotherapy, targeted therapy, etc.) or suspected tumor recurrence after previous treatment, and able to independently cooperate with relevant examinations.
  • Patients with clinically diagnosed HCC who have received 18F-FDG positron emission tomography/computed tomography (PET/CT) for clinical staging or post-treatment restaging, and able to independently cooperate with relevant examinations.

Exclusion Criteria:

  • Patients with severe non-malignant diseases that may interfere with study objectives, or impair subject safety and study compliance, including but not limited to psychiatric disorders, infectious diseases, autoimmune diseases, and metabolic diseases.
  • Pregnant or lactating females.
  • Subjects who are unable to understand the examination procedure or cannot cooperate with trial-related examinations and operations.

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: 18F-X12 PET/CT
The objective is to evaluate the diagnostic efficacy and safety of the novel radiotracer 18F-X12 in patients with hepatocellular carcinoma (HCC).
Diagnostic test: 18F-X12 PET/CT
Participants will receive a single intravenous injection of 18F-X12, and undergo PET/CT imaging approximately 120 minutes after radiotracer administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events [Safety and Tolerability]
Time Frame: 24 hours after the injection of 18F-X12
Clinical symptoms and adverse events (e.g., fever, rash, hypoglycemia) will be monitored within 24 hours after injection, and graded according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 6.0).
24 hours after the injection of 18F-X12
To evaluate the diagnostic efficacy of 18F-X12 PET/CT for hepatocellular carcinoma (HCC).
Time Frame: From study completion to 1 month after completion
We calculated the diagnostic sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-X12 positron emission tomography (PET) imaging for patients with hepatocellular carcinoma (HCC), with histopathological results as the diagnostic gold-standard reference.
From study completion to 1 month after completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized Uptake Values of Primary and Metastatic Lesions on ¹⁸F-X12 PET/CT versus ¹⁸F-FDG PET/CT
Time Frame: From the date of study completion up to 1-month post-completion
Comparison of the maximum standardized uptake value (SUVmax) and mean standardized uptake value (SUVmean) of primary and metastatic lesions between 18F-X12 positron emission tomography/computed tomography (PET/CT) and 18F-fluorodeoxyglucose (FDG) PET/CT.
From the date of study completion up to 1-month post-completion
Correlation between 18F-X12 Uptake and GPC3 Pathological Expression
Time Frame: From the date of study completion up to 1-month post-completion
We evaluated the correlation between uptake parameters derived from 18F-X12 positron emission tomography/computed tomography (PET/CT) and Glypican-3 (GPC3) expression levels measured by immunohistochemistry (IHC) in tumor tissue samples.
From the date of study completion up to 1-month post-completion

Collaborators and Investigators

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

Sponsor

Peking University First Hospital

Investigators

  • Principal Investigator: Meng Liu, Peking University First Hospital

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 (Actual)

August 25, 2026

Primary Completion (Estimated)

August 30, 2028

Study Completion (Estimated)

August 30, 2029

Study Registration Dates

First Submitted

August 26, 2026

First Submitted That Met QC Criteria

August 26, 2026

First Posted (Actual)

August 31, 2026

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 29, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FGPC3001

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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