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

May 12, 2026 updated by: Shu Wang, First Hospital of China Medical University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with Malignant Tumor

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Enrolled patients
Patients with Malignant Tumor
Device: 68Ga- DOTA-EphA2 PET/CT Imaging of Malignant Tumor
Study of the Radioligand 68Ga- DOTA-EphA2 for PET/CT Imaging of Malignant Tumor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From tracer administration to 24 hours after tracer injection.
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.
From tracer injection to completion of PET/CT imaging (approximately 2-3 hours).
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.
From tracer injection to completion of PET/CT imaging (approximately 2-3 hours).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Hospital of China Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 7, 2026

First Submitted That Met QC Criteria

May 12, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Approval No. [2025]669

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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