Recruiting

Evaluation of 18F-X12 for Diagnosis of Hepatocellular Carcinoma (HCC)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

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.

What is being tested

Simplified Title: 18F-X12 PET/CT Scan

Diagnostic Test
Who is being recruted

Adenocarcinoma+8

+ Carcinoma

+ Digestive System Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: August 2026
See protocol details

Summary

Principal SponsorPeking University First Hospital
Study ContactMeixi ChenMore contacts
Last updated: September 2, 2026
Sourced from a government-validated database.Claim as a partner

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).

Principal SponsorPeking University First Hospital
Study ContactMeixi ChenMore contacts
Last updated: September 2, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsLiver DiseasesLiver NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialCarcinoma, Hepatocellular

Criteria

5 inclusion criteria required to participate
Meet either of the following two conditions

Patients aged >= 18 years old

Patients fully understand the trial requirements, participate in the study voluntarily, and provide written informed consent

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

Show More Criteria

3 exclusion criteria prevent from participating
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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
This study aims to test the effectiveness and safety of a new imaging tracer, 18F-X12, in people with liver cancer (HCC).

Study 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

Recruiting

Peking University First Hospital

Beijing, ChinaOpen Peking University First Hospital in Google Maps
Recruiting
One Study Center