Malignant TumorEphA2NCT07593209
First-in-Human Study of the Radioligand 68Ga- DOTA-EphA2
An observational study of Malignant Tumor, run by First Hospital of China Medical University at 1 site in China.
Trial summary
Purpose Ephrin type-A receptor 2 (EphA2) is a receptor tyrosine kinase overexpressed in various solid tumors and associated with tumor progression, metastasis, and poor prognosis. However, noninvasive imaging tools for assessing EphA2 expression in vivo remain limited. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Tumor
- What is being tested?
- 68Ga- DOTA-EphA2 PET/CT Imaging of Malignant Tumor
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 31 Dec 2027
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Malignant Tumor
Who may be able to join
- Adults aged 18-80 years
- Patients with suspected or histologically confirmed malignant tumors At least one measurable lesion identified by conventional imaging (CT, MRI, or ultrasound)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Ability to understand the study procedures and provide written informed consent
- Adequate organ function allowing PET/CT examination
Who cannot join
- Pregnant or breastfeeding women
- Severe hepatic, renal, cardiovascular, or pulmonary dysfunction considered --unsuitable for PET/CT imaging
- Known allergy or hypersensitivity to study-related compounds
- Patients unable to tolerate PET/CT examination or remain still during image acquisition
- Participation in other investigational drug or radionuclide studies within 4 weeks prior to enrollment
- Any medical or psychiatric condition judged by the investigators to interfere with study participation or interpretation of imaging results
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, 1 recruiting
- Recruiting
PET
Shenyang, Liaoning, 110001
Shu Wang, PhD, 02483282611, shuwang201508@163.com
About this study
Official title: Development and Evaluation of 68Ga-DOTA-EphA2: A Novel Imaging Agent Targeting EphA2 for Malignant Tumor
Purpose Ephrin type-A receptor 2 (EphA2) is a receptor tyrosine kinase overexpressed in various solid tumors and associated with tumor progression, metastasis, and poor prognosis. However, noninvasive imaging tools for assessing EphA2 expression in vivo remain limited. This study aims to develop a novel 68Ga-labeled EphA2-targeting positron emission tomography (PET) tracer for specific imaging of EphA2-positive malignancies.
Read the detailed description
Purpose Ephrin type-A receptor 2 (EphA2) is a receptor tyrosine kinase overexpressed in various solid tumors and associated with tumor progression, metastasis, and poor prognosis. However, noninvasive imaging tools for assessing EphA2 expression in vivo remain limited. This study aims to develop a novel 68Ga-labeled EphA2-targeting positron emission tomography (PET) tracer for specific imaging of EphA2-positive malignancies.
- Conditions
- Malignant Tumor
- Being tested
- 68Ga- DOTA-EphA2 PET/CT Imaging of Malignant Tumor
- Keywords
- EphA2
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga- DOTA-EphA2 PET/CT Imaging of Malignant TumorDevice
Study of the Radioligand 68Ga- DOTA-EphA2 for PET/CT Imaging of Malignant Tumor
| Study group | Role | What they receive |
|---|---|---|
| Enrolled patients | Patients with Malignant Tumor Receives: Device: 68Ga- DOTA-EphA2 PET/CT Imaging of Malignant Tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events Following ⁶⁸Ga-NOTA-EphA2
Number of participants experiencing treatment-emergent adverse events (TEAEs) after administration of ⁶⁸Ga-NOTA-EphA2, graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From tracer administration to 24 hours after tracer injection.
Biodistribution of ⁶⁸Ga-NOTA-EphA2 Measured by Standardized Uptake Value (SUV)
Biodistribution of ⁶⁸Ga-NOTA-EphA2 in normal organs measured by maximum standardized uptake value (SUVmax) and mean standardized uptake value (SUVmean) on PET/CT imaging.
Measured: From tracer injection to completion of PET/CT imaging (approximately 2-3 hours).
Tumor Uptake of ⁶⁸Ga-NOTA-EphA2 on PET/CT
Tumor uptake of ⁶⁸Ga-NOTA-EphA2 measured by lesion SUVmax, SUVmean, and tumor-to-background ratio on PET/CT imaging.
Measured: From tracer injection to completion of PET/CT imaging (approximately 2-3 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 May 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant TumorStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu Wang, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593209
- Sponsor's protocol ID
- Approval No. [2025]669
- Acronym
- EphA2
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
Zhang MJ, Chen Y, Zhang C, Bian X, Zhang X, Huang S, Yang B, Lu S, Fu X, Zhao W, Kong XD, Zhao S. Development of a 177Lu-labeled EphA2-targeting cyclic peptide combined with an HPK1 inhibitor for synergistic anti-tumor effects. Cell Oncol (Dordr). 2025 Dec;48(6):1757-1774. doi: 10.1007/s13402-025-01105-1. Epub 2025 Oct 2.
PubMed 41037223
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of 68Ga-DOTA-EphA2: A Novel Imaging Agent Targeting EphA2 for Malignant Tumor
- ClinicalTrials.gov ID
- NCT07593209
- Acronym / sponsor ID
- EphA2 / Approval No. [2025]669
- Conditions
- Malignant Tumor
- Keywords
- EphA2
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 May 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.
Purpose Ephrin type-A receptor 2 (EphA2) is a receptor tyrosine kinase overexpressed in various solid tumors and associated with tumor progression, metastasis, and poor prognosis. However, noninvasive imaging tools for assessing EphA2 expression in vivo remain limited. This study aims to develop a novel 68Ga-labeled EphA2-targeting positron emission tomography (PET) tracer for specific imaging of EphA2-positive malignancies.
Detailed description
Purpose Ephrin type-A receptor 2 (EphA2) is a receptor tyrosine kinase overexpressed in various solid tumors and associated with tumor progression, metastasis, and poor prognosis. However, noninvasive imaging tools for assessing EphA2 expression in vivo remain limited. This study aims to develop a novel 68Ga-labeled EphA2-targeting positron emission tomography (PET) tracer for specific imaging of EphA2-positive malignancies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled patients | – | Device: 68Ga- DOTA-EphA2 PET/CT Imaging of Malignant TumorPatients with Malignant Tumor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Malignant Tumor
Key inclusion criteria (5 listed)
- Adults aged 18-80 years
- Patients with suspected or histologically confirmed malignant tumors At least one measurable lesion identified by conventional imaging (CT, MRI, or ultrasound)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Ability to understand the study procedures and provide written informed consent
- Adequate organ function allowing PET/CT examination
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women
- Severe hepatic, renal, cardiovascular, or pulmonary dysfunction considered --unsuitable for PET/CT imaging
- Known allergy or hypersensitivity to study-related compounds
- Patients unable to tolerate PET/CT examination or remain still during image acquisition
- Participation in other investigational drug or radionuclide studies within 4 weeks prior to enrollment
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- DOTA-EphA2 PET/CT Imaging of Malignant TumorStudy of the Radioligand 68Ga- DOTA-EphA2 for PET/CT Imaging of Malignant Tumor | Device | Enrolled patients |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events Following ⁶⁸Ga-NOTA-EphA2
Time frame: From tracer administration to 24 hours after tracer injection.
Number of participants experiencing treatment-emergent adverse events (TEAEs) after administration of ⁶⁸Ga-NOTA-EphA2, graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Biodistribution of ⁶⁸Ga-NOTA-EphA2 Measured by Standardized Uptake Value (SUV)
Time frame: From tracer injection to completion of PET/CT imaging (approximately 2-3 hours).
Biodistribution of ⁶⁸Ga-NOTA-EphA2 in normal organs measured by maximum standardized uptake value (SUVmax) and mean standardized uptake value (SUVmean) on PET/CT imaging.
Tumor Uptake of ⁶⁸Ga-NOTA-EphA2 on PET/CT
Time frame: From tracer injection to completion of PET/CT imaging (approximately 2-3 hours).
Tumor uptake of ⁶⁸Ga-NOTA-EphA2 measured by lesion SUVmax, SUVmean, and tumor-to-background ratio on PET/CT imaging.
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 18 May 2026.
- Background: PubMed 41037223Zhang MJ, Chen Y, Zhang C, Bian X, Zhang X, Huang S, Yang B, Lu S, Fu X, Zhao W, Kong XD, Zhao S. Development of a 177Lu-labeled EphA2-targeting cyclic peptide combined with an HPK1 inhibitor for synergistic anti-tumor effects. Cell Oncol (Dordr). 2025 Dec;48(6):1757-1774. doi: 10.1007/s13402-025-01105-1. Epub 2025 Oct 2.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Tumor, run by First Hospital of China Medical University 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 18 May 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.
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?
Contact Shu Wang, PhD (15040289429, shuwang201508@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events Following ⁶⁸Ga-NOTA-EphA2 (time frame: From tracer administration to 24 hours after tracer injection.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07593209, which also lists 1 linked publication.
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 18 May 2026.