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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-XH06.
- Who it may be relevant to
- Registry conditions: Malignant Neoplasm of Liver. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug 68Ga-XH06
For Cancer patients, subjects should have targeting GPC3 scans.
Primary outcome measures
- Visual and standardized uptake values assessment of lesions and biodistribution [Time frame: 1 year]
Secondary outcome measures (1)
- Pathological sections of tumour tissue [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Wuhan union hosptital — Wuhan
Identifiers
NCT: NCT07352345 · XLan-251020