Hepatocellular Carcinoma (HCC)NCT07795437
GPC3-Targeted PET Imaging of 18F-X12 in Hepatocellular Carcinoma
A study testing 18F-X12 PET/CT in people with Hepatocellular Carcinoma (HCC), run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- 18F-X12 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2026to 30 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, Municipality 100034
Peking University First Hospital, +86 010-83576401, bdyyll@126.com
About this study
Official title: Clinical Study of Glypican-3 (GPC3)-Targeted Novel Probe 18F-X12 for the Diagnosis of Hepatocellular Carcinoma (HCC)
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)
- Being tested
- 18F-X12 PET/CT
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-X12 PET/CTDiagnostic test
Participants will receive a single intravenous injection of 18F-X12, and undergo PET/CT imaging approximately 120 minutes after radiotracer administration.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: 18F-X12 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
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.
Measured: From the date of study completion up to 1-month post-completion
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.
Measured: From the date of study completion up to 1-month post-completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start25 Aug 2026
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng LIU, Peking University First Hospital
- Investigators
- Meng Liu, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795437
- Sponsor's protocol ID
- FGPC3001
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Glypican-3 (GPC3)-Targeted Novel Probe 18F-X12 for the Diagnosis of Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT07795437
- Acronym / sponsor ID
- FGPC3001
- Conditions
- Hepatocellular Carcinoma (HCC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-X12 PET/CT | Experimental | Diagnostic Test: 18F-X12 PET/CTThe objective is to evaluate the diagnostic efficacy and safety of the novel radiotracer 18F-X12 in patients with hepatocellular carcinoma (HCC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-X12 PET/CTParticipants will receive a single intravenous injection of 18F-X12, and undergo PET/CT imaging approximately 120 minutes after radiotracer administration. | Diagnostic test | 18F-X12 PET/CT |
Primary outcome
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.
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).
2 secondary outcomes
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
Correlation between 18F-X12 Uptake and GPC3 Pathological Expression
Time frame: From the date of study completion up to 1-month post-completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meng Liu principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-X12 PET/CT in people with Hepatocellular Carcinoma (HCC), run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meixi Chen (+86 010-83575252, 2511210177@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the diagnostic efficacy of 18F-X12 PET/CT for hepatocellular carcinoma (HCC). (time frame: From study completion to 1 month after completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.