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NCT Number: NCT07795437

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

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.

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Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, Municipality 100034, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

18F-X12 PET/CT

Diagnostic Test

Participants will receive a single intravenous injection of 18F-X12, and undergo PET/CT imaging approximately 120 minutes after radiotracer administration.

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

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Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 31, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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