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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• 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.

Trial sites (1)

More First Hospital of China Medical University trials in China

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