Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07593209

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Malignant Tumor Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shu Wang, PhD

CONTACT

[email protected]

15040289429

Sponsors and collaborators

Lead sponsor

First Hospital of China Medical University

Other

Registry information

Official study title

Development and Evaluation of 68Ga-DOTA-EphA2: A Novel Imaging Agent Targeting EphA2 for Malignant Tumor

Acronym: EphA2

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.