Evaluation of 18F-X12 for Diagnosis of Hepatocellular Carcinoma (HCC)
This study aims to evaluate the diagnostic efficacy of 18F-X12 PET/CT for detecting hepatocellular carcinoma (HCC), comparing it to histopathological results, while also monitoring the safety and tolerability of the procedure.
Simplified Title: 18F-X12 PET/CT Scan
Adenocarcinoma+8
+ Carcinoma
+ Digestive System Diseases
Diagnostic Study
Summary
Study start date: August 25, 2026
Actual date on which the first participant was enrolled.This clinical study focuses on a new diagnostic approach for hepatocellular carcinoma (HCC), a type of liver cancer. The study is evaluating a novel radiotracer, known as 18F-X12, which is designed to target a specific protein called Glypican-3 (GPC3) often found in HCC. The goal is to determine if this new method can help in early diagnosis, accurate staging, and assessment of cancer recurrence in patients with HCC. This research is important as it could potentially improve the way HCC is detected and managed, addressing current challenges in liver cancer care. During the study, participants with HCC will undergo a procedure called positron emission tomography (PET) imaging using the 18F-X12 radiotracer. This involves an injection of the radiotracer, followed by a scan to see how it interacts with the body. The study will measure the diagnostic efficacy of this method by comparing the results with histopathological findings, which are the current gold standard for diagnosis. Additionally, the safety and tolerability of 18F-X12 will be monitored, with any adverse events such as fever, rash, or hypoglycemia recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 6.0).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location