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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Number of Participants With Treatment-Emergent Adverse Events Following ⁶⁸Ga-NOTA-EphA2 [Срок оценки: From tracer administration to 24 hours after tracer injection.]
• Biodistribution of ⁶⁸Ga-NOTA-EphA2 Measured by Standardized Uptake Value (SUV) [Срок оценки: From tracer injection to completion of PET/CT imaging (approximately 2-3 hours).]
• Tumor Uptake of ⁶⁸Ga-NOTA-EphA2 on PET/CT [Срок оценки: From tracer injection to completion of PET/CT imaging (approximately 2-3 hours).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Китай · 1 центр

• PET — Шэньян

Публикации

• 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

Идентификаторы

NCT: NCT07593209 · Approval No. [2025]669

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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