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NCT Number: NCT07352345

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

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.

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Key information

Conditions

Malignant Neoplasm of Liver Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntary participation and the patient or their legal representative is able to sign an informed consent form
  • 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

Treatment and study plan

68Ga-XH06

Drug

For Cancer patients, subjects should have targeting GPC3 scans.

Primary outcomes

  1. Visual and standardized uptake values assessment of lesions and biodistribution

    Time frame: 1 year

    At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of tumor and organs will be measured after a semiquantitative analysis is conducted for each case. The SUV ranges from 0 to infinity, and a higher score means a higher uptake of targeting GPC3 nuclear probe by the tumor, which implies a greater threat of the tumor being malignant or higher stage.

Secondary outcomes

  1. Pathological sections of tumour tissue

    Time frame: 1 year

    The excised tumour tissue was taken for immunohistochemistry to verify its GPC3 expression

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoli Lan, PhD

CONTACT

[email protected]

0086-027-83692633

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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