Recruiting NCT07593209

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

— Observational Malignant Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: 68Ga- DOTA-EphA2 PET/CT Imaging of Malignant Tumor.
Who it may be relevant to: Registry conditions: Malignant Tumor. Basic parameters: 18 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

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

Primary outcome measures

Number of Participants With Treatment-Emergent Adverse Events Following ⁶⁸Ga-NOTA-EphA2 [Time frame: 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).]
Tumor Uptake of ⁶⁸Ga-NOTA-EphA2 on PET/CT [Time frame: From tracer injection to completion of PET/CT imaging (approximately 2-3 hours).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Case-only

Study locations

China · 1 center

PET — Shenyang

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. PMID 41037223

Identifiers

NCT: NCT07593209 · Approval No. [2025]669

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗