First-in-Human Study of the Radioligand 68Ga- DOTA-EphA2
ConditionMalignant Tumor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFirst Hospital of China Medical University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with Malignant Tumor
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
68Ga- DOTA-EphA2 PET/CT Imaging of Malignant Tumor
DeviceStudy of the Radioligand 68Ga- DOTA-EphA2 for PET/CT Imaging of Malignant Tumor
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Enrolled patients1 intervention
Trial outcomes
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov