Malignant Tumor
Conditions
Keywords
EphA2
Brief 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.
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.
Interventions
DEVICE68Ga- DOTA-EphA2 PET/CT Imaging of Malignant Tumor
Study of the Radioligand 68Ga- DOTA-EphA2 for PET/CT Imaging of Malignant Tumor
Sponsors
First Hospital of China Medical University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events Following ⁶⁸Ga-NOTA-EphA2 | 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. |
| Biodistribution of ⁶⁸Ga-NOTA-EphA2 Measured by Standardized Uptake Value (SUV) | 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. |
| Tumor Uptake of ⁶⁸Ga-NOTA-EphA2 on PET/CT | 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. |
Countries
China
Contacts
CONTACTShu Wang, PhD
Outcome results
None listed