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Enrolling by invitation NCT07741006

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

Early Phase I Interventional Malignant Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [68Ga]Ga-ELI411.
Who it may be relevant to
Registry conditions: Malignant Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug [68Ga]Ga-ELI411
    For Cancer patients, subjects should have target FAP protein.

Primary outcome measures

  • Semiquantitative SUV Parameters of Lesions on [68Ga]Ga-ELI411 PET [Time frame: 7 days]
Secondary outcome measures (1)
  • Semiquantitative imaging metrics of Lesions on [68Ga]Ga-ELI411 PET [Time frame: 7 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Union Hospital, Huazhong University of Science and Technology — Wuhan

Identifiers

NCT: NCT07741006 · Xlan-20260326

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗