ClinicalTrials.gg
RecruitingNCT07593209EphA2Updated May 18, 2026

First-in-Human Study of the Radioligand 68Ga- DOTA-EphA2

An observational study in Malignant Tumor, sponsored by First Hospital of China Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by First Hospital of China Medical University · Observational

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Malignant Tumor

Browse trials for

Keywords

  • EphA2
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 30 is below the median of 200 across 2,638 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

First Hospital of China Medical University is the lead sponsor of 62 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with Malignant Tumor

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18-80 years
  • Patients with suspected or confirmed malignant tumors At least one identified by conventional imaging (CT, MRI, or ultrasound)
  • (ECOG) performance status of 0-2
  • Ability to understand the study procedures and provide written
  • Adequate organ function allowing PET/CT examination

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Severe hepatic, renal, cardiovascular, or pulmonary dysfunction considered --unsuitable for PET/CT imaging
  • Known allergy or to study-related compounds
  • Patients unable to tolerate PET/CT examination or remain still during image acquisition
  • Participation in other 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
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Enrolled patients

    Patients with Malignant Tumor

    Device: 68Ga- DOTA-EphA2 PET/CT Imaging of Malignant Tumor

Interventions

  • Device68Ga- DOTA-EphA2 PET/CT Imaging of Malignant Tumor

    Study of the Radioligand 68Ga- DOTA-EphA2 for PET/CT Imaging of Malignant Tumor

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From tracer administration to 24 hours after tracer injection.

  2. 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.

    Time frame: From tracer injection to completion of PET/CT imaging (approximately 2-3 hours).

  3. 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.

    Time frame: From tracer injection to completion of PET/CT imaging (approximately 2-3 hours).

07

Study locations

1 of 1 sites recruiting
  • PET
    Shenyang, Liaoning 110001, China
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07593209
Lead sponsor
First Hospital of China Medical University
Responsible party
Shu Wang (Nuclear Medicine, First Hospital of China Medical University) — Principal investigator
First posted
May 18, 2026
Start date
May 1, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
May 18, 2026

Study contacts

Shu Wang, PhD
Contact
shuwang201508@163.com
15040289429

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion