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

NCT07741006 | Enrolling By Invitation Early Phase 1

• 1 other identifier: Xlan-20260326
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Solid Tumor

Keywords

FAP; Fibroblast Activation Protein; PET; Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Semiquantitative SUV Parameters of Lesions on [68Ga]Ga-ELI411 PET

  Semiquantitative imaging metrics measured from \[68Ga\]Ga-ELI411 PET lesions（SUVmax of target lesions）.

  7 days

Secondary Outcomes (1)

• Semiquantitative imaging metrics of Lesions on [68Ga]Ga-ELI411 PET

  7 days

Study Arms (1)

[68Ga]Ga-ELI411 PET Imaging

EXPERIMENTAL

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.

Drug: [68Ga]Ga-ELI411

Interventions

[68Ga]Ga-ELI411 DRUG

For Cancer patients, subjects should have target FAP protein.

[68Ga]Ga-ELI411 PET Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Union Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: August 3, 2026
• Study Start: June 28, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)