TheranosticTrials.org

Clinical Trial · NCT06383520

Study on the Clinical Application Value of PET Imaging Targeting GPC3 in Hepatocellular Carcinoma

Overview

This is a diagnostic study. Patients were recruited from patients with clinically suspected or confirmed hepatocellular carcinoma and healthy volunteers were recruited for PET/or PET/CT imaging targeting a GPC3-specific probe (in the case of 68Ga-NOTA-aGPC3-scFv) , to observe the reaction of volunteers and patients after injection of drugs, to evaluate the pharmacokinetics in vivo and the efficacy of diagnosis and staging, and to perform PET CT imaging in patients with contraindications. General Information, clinical data, blood routine, liver and renal function, and other imaging data were collected. The final diagnosis was based on the histopathology of biopsy or surgical specimens.

Sponsor

Norwegian University of Science and Technology

Phase

Early Phase 1

Contacts

Xiaoli Lan, PhD (CONTACT)

lxl730724@hotmail.com

0086-027-83692633

Xiaoli Lan, PhD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT06383520

Drug / Compound

aGPC3-scFv/Fab

Isotope(s):
Target(s):
  • GPC3
Ligand Class: Small Proteins and Antibody Fragments
Chelator: NOTA

Eligibility

Inclusion

  • 3: Patients with newly diagnosed hepatocellular carcinoma with high clinical suspicion or confirmation (supporting evidence including imaging data and histopathologic examination, etc.) who agree to undergo histopathologic examination (if not performed prior to imaging) or/and 18F-FDG PET imaging
  • 6: Willing and able to follow schedule visits, treatment plans and laboratory tests
  • 5: Patients with a history of hepatocellular carcinoma, remission and recurrence after treatment
  • 4: Healthy volunteer

Exclusion

  • 5: Fasting blood glucose levels exceeding 11.0 mmol/L before injection of 18F-FDG
  • 6: Individuals who are unable to complete PET/MR or PET/CT examinations (including inability to lie flat, claustrophobia, radiation phobia, etc.)
  • 3: Acute systemic diseases and electrolyte disorders
  • 4: Patients who are known to be allergic to GPC3 imaging agents or synthetic excipients
  • 7: Researchers believe that compliance is poor or there are other unfavorable factors for participating in this experiment
  • 1: Pregnant or lactating patients