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ENROLLING BY INVITATION

NCT07741006

EARLY_PHASE1

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

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

Summary

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.

Official title: A Single-Center, Prospective, Open-Label, Two-Cohort Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Diagnostic Performance of [68Ga]Ga-ELI411 PET Imaging in Chinese Adult Patients With Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06-28

Completion Date

2027-05-30

Last Updated

2026-08-03

Healthy Volunteers

Conditions

Malignant Solid Tumor

Interventions

DRUG

[68Ga]Ga-ELI411

For Cancer patients, subjects should have target FAP protein.

Inclusion Criteria: * Written informed consent obtained prior to the performance of any study-specific procedures. * Adults aged 18 years or older. * Histologically, cytologically, or clinically confirmed malignant solid tumor. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Clinical indication for \^18F-FDG PET imaging. * No clinically significant abnormalities in physical examination, vital signs, laboratory tests, or 12-lead electrocardiogram that, in the investigator's judgment, would interfere with study participation or image interpretation. * Women of childbearing potential must have a negative pregnancy test prior to administration of the investigational radiotracer. * Participants of childbearing potential (male and female) must agree to use highly effective contraception during the study and for at least 6 months after administration of the investigational radiotracer, and must refrain from sperm or oocyte donation during this period. * Willing and able to comply with all study procedures and follow-up requirements. Exclusion Criteria: * Any concomitant disease or medical condition that, in the investigator's judgment, could compromise participant safety or interfere with image interpretation. * Concomitant medications or therapies that may affect the safety, biodistribution, radiation dosimetry, or diagnostic performance of the investigational radiotracer. * Previous anticancer treatment (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, radionuclide therapy, or major surgery) without an adequate washout period, as determined by the investigator. * Known hypersensitivity to gallium-containing radiopharmaceuticals, ethanol, any component of the investigational product, or a history of severe allergic reactions. * Pregnant or breastfeeding women. * Inability to undergo PET/CT imaging or comply with study procedures. Participation in another interventional clinical trial that, in the investigator's judgment, could interfere with this study. * Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.

Locations (1)

Union Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China