Malignant Neoplasm of Liver
Conditions
Brief summary
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
DRUG68Ga-XH06
For Cancer patients, subjects should have targeting GPC3 scans.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual and standardized uptake values assessment of lesions and biodistribution | 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
| Measure | Time frame | Description |
|---|---|---|
| Pathological sections of tumour tissue | 1 year | The excised tumour tissue was taken for immunohistochemistry to verify its GPC3 expression |
Countries
China
Contacts
CONTACTXiaoli Lan, PhD
Outcome results
None listed