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

NCT07795437 | Recruiting

• 1 other identifier: FGPC3001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (2)

• To evaluate the diagnostic efficacy of 18F-X12 PET/CT for hepatocellular carcinoma (HCC).

  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

• Incidence of Adverse Events [Safety and Tolerability]

  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

Secondary Outcomes (2)

• Standardized Uptake Values of Primary and Metastatic Lesions on ¹⁸F-X12 PET/CT versus ¹⁸F-FDG PET/CT

  From the date of study completion up to 1-month post-completion

• Correlation between 18F-X12 Uptake and GPC3 Pathological Expression

  From the date of study completion up to 1-month post-completion

Study Arms (1)

18F-X12 PET/CT

EXPERIMENTAL

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

Interventions

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.

18F-X12 PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, Municipality 100034, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Meng Liu

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meixi Chen

CONTACT

+86 010-83575252; 2511210177@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: August 25, 2026
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2029
• Last Updated: September 2, 2026

Record last verified: 2026-08

Locations

CN (1)