Clinical trial · Interventional
Clinical Evaluation of [68Ga]Ga-ELI411 PET Imaging in Adult Patients With Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Solid Tumor | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]Ga-ELI411 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [68Ga]Ga-ELI411 PET Imaging
- description
- Participants will receive a single intravenous administration of \[68Ga\]Ga-ELI411 followed by serial PET imaging for evaluation of biodistribution, radiation dosimetry, safety and diagnostic performance.
- interventionNames
- Drug: [68Ga]Ga-ELI411
Primary outcomes (1)
- measure
- Semiquantitative SUV Parameters of Lesions on [68Ga]Ga-ELI411 PET
- timeFrame
- 7 days
- description
- Semiquantitative imaging metrics measured from \[68Ga\]Ga-ELI411 PET lesions（SUVmax of target lesions）.
Secondary outcomes (1)
- measure
- Semiquantitative imaging metrics of Lesions on [68Ga]Ga-ELI411 PET
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available