XCancer

Clinical Evaluation of [68Ga]Ga-ELI411 PET Imaging in Adult Patients With Solid Tumors

Description:

This is a prospective, single-center, open-label, two-cohort clinical study evaluating the safety, tolerability, biodistribution, radiation dosimetry, and diagnostic performance of \[68Ga\]Ga-ELI411 PET imaging in adult patients with solid tumors. Eligible patients with an indication for 18F-FDG PET imaging will receive a single intravenous administration of \[68Ga\]Ga-ELI411 followed by serial PET imaging. Imaging findings will be compared with conventional imaging, histopathology, and clinical follow-up when applicable. The study will also evaluate tracer biodistribution, radiation dosimetry, and lesion detection performance compared with standard 18F-FDG PET imaging.

Sponsor:

Norwegian University of Science and Technology

Phase:

Early Phase 1

Government Study Link:

NCT07741006 - Click here to see study on

ClinicalTrials.gov

ELI411

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Inclusion
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Histologically, cytologically, or clinically confirmed malignant solid tumor.
  • Clinical indication for \^18F-FDG PET imaging.
Exclusion
  • Previous anticancer treatment (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, radionuclide therapy, or major surgery) without an adequate washout period, as determined by the investigator.