GPC3-Targeted PET Imaging of 18F-X12 in Hepatocellular Carcinoma
ConditionHepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University First Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients aged ≥ 18 years old.
Patients fully understand the trial requirements, participate in the study voluntarily, and provide written informed consent.
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
18F-X12 PET/CT
Diagnostic testParticipants will receive a single intravenous injection of 18F-X12, and undergo PET/CT imaging approximately 120 minutes after radiotracer administration.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: 18F-X12 PET/CTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From study completion to 1 month after completion2
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).
Time frame
24 hours after the injection of 18F-X12Secondary outcomes
1
Standardized Uptake Values of Primary and Metastatic Lesions on ¹⁸F-X12 PET/CT versus ¹⁸F-FDG PET/CT
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.
Time frame
From the date of study completion up to 1-month post-completion2
Correlation between 18F-X12 Uptake and GPC3 Pathological Expression
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.
Time frame
From the date of study completion up to 1-month post-completionSponsors and contacts
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Source ClinicalTrials.gov