PET imaging targeting GPC3 for liver cancer diagnosis

Study on the Clinical Application Value of PET Imaging Targeting GPC3 in Hepatocellular Carcinoma

This study is testing a new type of PET imaging to see if it can help doctors better diagnose liver cancer in patients who might have it.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (other)
• Drugs / interventions: radiation
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06383520 on ClinicalTrials.gov

What this trial studies

This clinical trial focuses on the use of PET imaging with a GPC3-specific probe to improve the diagnosis and staging of hepatocellular carcinoma (HCC). Patients with suspected or confirmed HCC, as well as healthy volunteers, will undergo PET/CT imaging to evaluate the pharmacokinetics and efficacy of the imaging agent. The study aims to collect clinical data and imaging results to enhance early detection methods for HCC, which is often diagnosed at an advanced stage. The final diagnosis will be confirmed through histopathological examination of biopsy or surgical specimens.

Who should consider this trial

Good fit: Ideal candidates include adults with newly diagnosed hepatocellular carcinoma or those with a history of the disease who are willing to participate.

Not a fit: Patients who are pregnant, lactating, or have acute systemic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier and more accurate diagnosis of hepatocellular carcinoma, potentially improving patient outcomes.

How similar studies have performed: While traditional imaging methods have limitations, this novel approach using GPC3-targeted PET imaging has not been widely tested, making it a potentially groundbreaking method.

Eligibility criteria

Inclusion Criteria:

* 1: Voluntarily participate and the person or their legal representative can sign an informed consent form
* 2: Adult patients (18 years of age or older), regardless of gender
* 3: Patients with newly diagnosed hepatocellular carcinoma with high clinical suspicion or confirmation (supporting evidence including imaging data and histopathologic examination, etc.) who agree to undergo histopathologic examination (if not performed prior to imaging) or/and 18F-FDG PET imaging
* 4: Healthy volunteer
* 5: Patients with a history of hepatocellular carcinoma, remission and recurrence after treatment
* 6: Willing and able to follow schedule visits, treatment plans and laboratory tests

Exclusion Criteria:

* 1: Pregnant or lactating patients
* 2: The patient or their legal representative is unable or unwilling to sign the informed consent form
* 3: Acute systemic diseases and electrolyte disorders
* 4: Patients who are known to be allergic to GPC3 imaging agents or synthetic excipients
* 5: Fasting blood glucose levels exceeding 11.0 mmol/L before injection of 18F-FDG
* 6: Individuals who are unable to complete PET/MR or PET/CT examinations (including inability to lie flat, claustrophobia, radiation phobia, etc.)
* 7: Researchers believe that compliance is poor or there are other unfavorable factors for participating in this experiment

Where this trial is running

Wuhan, Hubei

• China, Hubei Province — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Study coordinator: Xiaoli Lan, PhD

Conditions: Malignant Neoplasm of Liver