Hepatocellular Carcinoma
Conditions
Interventions
Experimental group:All enrolled subjects will receive a single intravenous injection of 68Ga-GPC3-XT at a dose of 3–5 mCi per administration. 68Ga-RAYZ-8009 will be administered as a comparator agent
Sponsors
Chinese People's Liberation Army (PLA) General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily provide written informed consent after full understanding of the study; 2. Aged >= 18 years; 3. Patients with clinically highly suspected or primary HCC (supported by imaging and/or histopathological findings) who are scheduled for surgical resection or biopsy; or patients with pathologically confirmed HCC who present with clinical or imaging evidence of recurrence or distant metastasis; 4. Female participants of reproductive age must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to investigational product administration; 5. Participants agree to use effective contraception (e.g., condoms, oral contraceptives, injectable contraceptives) from signing informed consent through 6 months post-administration.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to the investigational drug or any of its components/analogues; 2. Any uncontrolled disease, psychiatric disorder, or surgical condition that could compromise study completion or preclude safe administration of the investigational product, including but not limited to New York Heart Association (NYHA) Class III/IV congestive heart failure, history of congenital long QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant concomitant illnesses; 3. Any disease or condition that, in the opinion of the investigator, would make the participant inappropriate for receipt of the investigational drug; 4. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| SUVmax;Sensitivity, SE;Specificity, SP; | — |
Countries
China
Contacts
Public ContactJinming Zhang
Chinese People's Liberation Army (PLA) General Hospital
Outcome results
None listed