Malignant Solid TumorEarly Phase 1NCT07741006
Clinical Evaluation of [68Ga]Ga-ELI411 PET Imaging in Adult Patients With Solid Tumors
A Early Phase 1 study testing [68Ga]Ga-ELI411 in people with Malignant Solid Tumor, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumor
- What is being tested?
- [68Ga]Ga-ELI411
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2026to 30 May 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei
About this study
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
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
- Being tested
- [68Ga]Ga-ELI411
- Keywords
- FAP, Fibroblast Activation Protein, PET, Solid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-ELI411Drug
For Cancer patients, subjects should have target FAP protein.
| Study group | Role | What they receive |
|---|---|---|
| [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. Receives: Drug: [68Ga]Ga-ELI411 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semiquantitative SUV Parameters of Lesions on [68Ga]Ga-ELI411 PET
Semiquantitative imaging metrics measured from [68Ga]Ga-ELI411 PET lesions（SUVmax of target lesions）.
Measured: 7 days
Secondary outcomes (1)
Semiquantitative imaging metrics of Lesions on [68Ga]Ga-ELI411 PET
Semiquantitative imaging metrics (tumor-to-background ratios) of [68Ga]Ga-ELI411 PET lesions
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start28 Jun 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741006
- Sponsor's protocol ID
- Xlan-20260326
- Status last verified
- May 2026
- First submitted
- 1 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07741006
- Acronym / sponsor ID
- Xlan-20260326
- Conditions
- Malignant Solid Tumor
- Keywords
- FAP, Fibroblast Activation Protein, PET, Solid Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 28 Jun 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-ELI411 PET Imaging | Experimental | Drug: [68Ga]Ga-ELI411Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-ELI411For Cancer patients, subjects should have target FAP protein. | Drug | [68Ga]Ga-ELI411 PET Imaging |
Primary outcome
Semiquantitative SUV Parameters of Lesions on [68Ga]Ga-ELI411 PET
Time frame: 7 days
Semiquantitative imaging metrics measured from [68Ga]Ga-ELI411 PET lesions（SUVmax of target lesions）.
1 secondary outcome
Semiquantitative imaging metrics of Lesions on [68Ga]Ga-ELI411 PET
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [68Ga]Ga-ELI411 in people with Malignant Solid Tumor, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semiquantitative SUV Parameters of Lesions on [68Ga]Ga-ELI411 PET (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.