RecruitingNCT07593209

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

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

Sponsor

First Hospital of China Medical University

Enrollment

30 participants

Start Date

May 1, 2026

Study Type

OBSERVATIONAL

Conditions

Malignant Tumor

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

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 Criteria6

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