Head to Head, Prospective, Open Label Multicenter Study on the Diagnostic Efficacy of GPC3 Targeted PET Imaging and Enhanced Magnetic Resonance Imaging for Hepatocellular Carcinoma

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Malignant Neoplasm of Liver

Treatments: Drug: 68Ga-XH06

Study type: Interventional

Funder types: Other

Identifiers

NCT07352345

XLan-251020

Details and patient eligibility

About

This project intends to apply XH06 PET/CT or PET/MR imaging to patients suspected or diagnosed with hepatocellular carcinoma (liver mass), and compare it with enhanced magnetic resonance imaging. Using surgical/biopsy pathology as the gold standard, the diagnostic efficacy of XH06 PET/CT or PET/MR imaging for primary and metastatic lesions of hepatocellular carcinoma will be evaluated. The purpose is to further confirm the advantages of XH06 PET/CT or PET/MR in the diagnosis and staging of hepatocellular carcinoma through prospective, multicenter clinical studies, to compensate for the shortcomings of conventional imaging techniques in the diagnosis and staging of hepatocellular carcinoma, and to provide more accurate information to guide clinical treatment decisions for hepatocellular carcinoma.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Voluntary participation and the patient or their legal representative is able to sign an informed consent form
2. Adult patients (aged 18 or above), regardless of gender 3: Patients with newly diagnosed hepatocellular carcinoma who are highly suspected or confirmed clinically (supporting evidence includes imaging data and histopathological examination, etc.) and agree to undergo histopathological examination (if not performed before imaging) 4: Patients with expected survival>3 months 5: Willing and able to follow schedule visits, treatment plans, laboratory and other relevant examinations

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 imbalances

  4: Patients known to be allergic to XH06 imaging agent or synthetic excipients

  5: Individuals who are unable to complete PET/MR or PET/CT examinations (including inability to lie flat, claustrophobia, radiation phobia, etc.)

  6: Researchers believe that those with poor compliance or other factors that are not suitable for participating in this trial

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

150 participants in 1 patient group

PET imaging targeting GPC3 in hepatocellular carcinoma

Experimental group

Description:

Determine if targeting GPC3 PET is safe and effective method for imaging of hepatocellular carcinoma

Treatment:

Drug: 68Ga-XH06