Hepatocellular Carcinoma (HCC)NCT07677774
GPC3-Targeted PET/CT in Hepatocellular Carcinoma
A study testing GPC3-targeted PET/CT in people with Hepatocellular Carcinoma (HCC) and Glypican-3, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
The objective of the study is to evaluate the diagnostic value of GPC3-targeted PET/CT in patients with suspected or histologically/clinically confirmed hepatocellular carcinoma, and to compare with contrast-enhanced MRI. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Glypican-3, GPC3-targeted PET/CT
- What is being tested?
- GPC3-targeted PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 31 May 2027
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (aged 18 years or older);
- Patients with suspected, newly diagnosed, or previously treated hepatocellular carcinoma(supporting evidence may include imaging findings and pathology report);
- Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
- Estimated life expectancy of more than 3 months, as assessed by the investigator, and ability to comply with study procedures and scheduled visits;
Who cannot join
- Lack of contrast-enhanced liver MRI or an interval of more than 14 days between GPC3-targeted PET/CT and contrast-enhanced liver MRI.
- Receipt of antitumor treatment between imaging examinations.
- The inability or unwillingness of the research participant or legal representative to provide written informed consent.
- Inability to complete PET/CT imaging.
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
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
Liang Zhao, 86 18818350620, wzhaoliang01@163.com
Haojun Chen, 86 18659285282, leochen0821@foxmail.com
About this study
Official title: Glypian-3 (GPC3)- Targeted PET Imaging in Hepatocellular Carcinoma
The objective of the study is to evaluate the diagnostic value of GPC3-targeted PET/CT in patients with suspected or histologically/clinically confirmed hepatocellular carcinoma, and to compare with contrast-enhanced MRI.
Read the detailed description
This study is designed to investigate GPC3-targeted PET/CT as a noninvasive approach for detecting tumor lesions in patients with suspected or histologically/clinically confirmed hepatocellular carcinoma. In this research, eligible patients will undergo contemporaneous GPC3-targeted PET/CT and contrast-enhanced liver MRI plus conventional extrahepatic imaging either for initial assessment or for metastases or highly suspected recurrence detection. Tumor uptake will be quantified by the maximum standardized uptake value (SUVmax). Positive lesions detected by contrast-enhanced liver MRI + conventional imaging and GPC3-targeted PET/CT will be recorded by visual interpretation and compared. Imaging findings will be compared with pathological result and/or a composite reference standard incorporating radiologic follow-up, clinical course, and treatment response..
- Being tested
- GPC3-targeted PET/CT
- Keywords
- Hepatocellular Carcinoma, Glypican-3, GPC3-targeted PET/CT, HCC, PET/CT
- Medical subject headings
- Carcinoma, Hepatocellular, Simpson-Golabi-Behmel syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPC3-targeted PET/CTDiagnostic test
Participants will receive a single intravenous injection of 68Ga-GPC3, and undergo PET/CT imaging within the specified time.
| Study group | Role | What they receive |
|---|---|---|
| GPC3-targeted PET/CT | Experimental | Each subject receives a single intravenous injection of GPC3-targeted probe and undergoes PET/CT imaging within the specified time. Receives: Diagnostic Test: GPC3-targeted PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
The sensitivity, specificity, and accuracy of GPC3-targeted PET/CT and CE-MRI in detecting malignant hepatic lesions were calculated and compared.
Measured: 1 year
Secondary outcomes (3)
Agreement of BCLC classification with the reference classification
The agreement of Barcelona Clinic Liver Cancer (BCLC) classification based on GPC3-targeted PET/CT with the reference BCLC classification will be assessed and compared with that based on conventional imaging, consisting of CE-MRI plus chest CT and other clinically indicated conventional imaging modalities.
Unit of Measure: Proportion of patients with correct BCLC classification (%)
Measured: 1 year
Lesion detection by GPC3-targeted PET/CT compared with 18F-FDG PET/CT
In patients who undergo both examinations, the detection rates of reference-positive malignant lesions by GPC3-targeted PET/CT and 18F-FDG PET/CT will be calculated and compared, including hepatic lesions, metastatic lymph nodes, and distant metastases.
Unit of Measure: Lesion detection rate (%)
Measured: Within 14 days
Gastric SUVmax Stratified by Gastric Filling Status
Gastric filling status will be assessed on the low-dose CT component of PET/CT imaging and categorized according to the degree of gastric distension. Tracer uptake in the stomach will be quantified using SUVmax and SUVmean.
Unit of Measure, SUVmax; SUVmean.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 May 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (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 The First Affiliated Hospital of Xiamen UniversityThe 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
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677774
- Sponsor's protocol ID
- XMYY-2025KY019
- Status last verified
- May 2026
- First submitted
- 8 Jun 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glypian-3 (GPC3)- Targeted PET Imaging in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07677774
- Acronym / sponsor ID
- XMYY-2025KY019
- Keywords
- Hepatocellular Carcinoma, Glypican-3, GPC3-targeted PET/CT, HCC, PET/CT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 1 Jul 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.
The objective of the study is to evaluate the diagnostic value of GPC3-targeted PET/CT in patients with suspected or histologically/clinically confirmed hepatocellular carcinoma, and to compare with contrast-enhanced MRI.
Detailed description
This study is designed to investigate GPC3-targeted PET/CT as a noninvasive approach for detecting tumor lesions in patients with suspected or histologically/clinically confirmed hepatocellular carcinoma. In this research, eligible patients will undergo contemporaneous GPC3-targeted PET/CT and contrast-enhanced liver MRI plus conventional extrahepatic imaging either for initial assessment or for metastases or highly suspected recurrence detection. Tumor uptake will be quantified by the maximum standardized uptake value (SUVmax). Positive lesions detected by contrast-enhanced liver MRI + conventional imaging and GPC3-targeted PET/CT will be recorded by visual interpretation and compared. Imaging findings will be compared with pathological result and/or a composite reference standard incorporating radiologic follow-up, clinical course, and treatment response..
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GPC3-targeted PET/CT | Experimental | Diagnostic Test: GPC3-targeted PET/CTEach subject receives a single intravenous injection of GPC3-targeted probe and undergoes PET/CT imaging within the specified time. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (aged 18 years or older);
- Patients with suspected, newly diagnosed, or previously treated hepatocellular carcinoma(supporting evidence may include imaging findings and pathology report);
- Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
- Estimated life expectancy of more than 3 months, as assessed by the investigator, and ability to comply with study procedures and scheduled visits;
Key exclusion criteria (4 listed)
- Lack of contrast-enhanced liver MRI or an interval of more than 14 days between GPC3-targeted PET/CT and contrast-enhanced liver MRI.
- Receipt of antitumor treatment between imaging examinations.
- The inability or unwillingness of the research participant or legal representative to provide written informed consent.
- Inability to complete PET/CT imaging.
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 |
|---|---|---|
| GPC3-targeted PET/CTParticipants will receive a single intravenous injection of 68Ga-GPC3, and undergo PET/CT imaging within the specified time. | Diagnostic test | GPC3-targeted PET/CT |
Primary outcome
Diagnostic accuracy
Time frame: 1 year
The sensitivity, specificity, and accuracy of GPC3-targeted PET/CT and CE-MRI in detecting malignant hepatic lesions were calculated and compared.
3 secondary outcomes
Agreement of BCLC classification with the reference classification
Time frame: 1 year
Lesion detection by GPC3-targeted PET/CT compared with 18F-FDG PET/CT
Time frame: Within 14 days
Gastric SUVmax Stratified by Gastric Filling Status
Time frame: 1 day
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 10 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GPC3-targeted PET/CT in people with Hepatocellular Carcinoma (HCC) and Glypican-3, run by The First Affiliated Hospital of Xiamen University 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 4 inclusion and 4 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 10 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 Liang Zhao (86 18818350620, wzhaoliang01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: 1 year). 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 10 Sep 2026.