ImmunoPET Targeting Trophoblast Cell-Surface Antigen 2 (Trop-2) in Thyroid Cancer and Compared With 18F-FDG
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Diagnostic performance (patient-based)
研究概览
简要总结
In this study, we comprehensively evaluated the clinical utility of Trop2 PET/CT (68Ga-MY6349 PET/CT) imaging for detecting recurrent and metastatic thyroid cancer, and the results were compared with those of 18F-FDG PET/CT. The primary objective of this study was to evaluate the patient-based sensitivity of 68Ga-MY6349 PET/CT in detecting recurrent and metastatic thyroid cancer. The secondary objectives included its overall specificity, lesion-based diagnostic performance, comparative tumor uptake relative to 18F-FDG PET/CT, safety profile, and the impact on clinical management.
详细描述
Trophoblast cell-surface antigen 2 (Trop2), a transmembrane glycoprotein, is highly expressed in most epithelial cancers but has low expression in most normal tissues. Notably, Trop2 expression is significantly elevated in thyroid cancer, representing an important molecular hallmark of thyroid cancer. Previously, we developed a Trop2-specific radiotracer for PET/CT imaging, 68Ga-MY6349, with the potential for clinical translation across various cancer types. In particular, 68Ga-MY6349 PET/CT demonstrated the highest tumor uptake in PTC across 15 cancer types, enabling visualization of more metastatic lesions than conventional 18F-FDG PET/CT.
In this study, we comprehensively evaluated the clinical utility of Trop2 PET/CT imaging for detecting recurrent and metastatic thyroid cancer, and the results were compared with standard-of-care imaging (18F-FDG PET/CT). The primary objective of this study was to evaluate the patient-based sensitivity of 68Ga-MY6349 PET/CT in detecting recurrent and metastatic thyroid cancer. The secondary objectives included its overall specificity, lesion-based diagnostic performance, comparative tumor uptake relative to 18F-FDG PET/CT, safety profile, and the impact on clinical management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (aged 18 years or older);
- •Patients with a history of previously treated thyroid cancer, including DTC and HGFCTC following thyroidectomy with or without 131I therapy, MTC after thyroidectomy, or ATC; either (1) evidence of structural or suspicious lesions on standard of care imaging or (2) biochemical evidence of disease in the absence of structural findings, defined as elevated thyrotropin suppressed thyroglobulin (Tgon ≥1 ng/mL after 131I ablation or ≥5 ng/mL without ablation) with negative anti thyroglobulin antibodies (<20 IU/mL) for DTC and HGFCTC or elevated calcitonin (>10 pg/mL) for MTC;
- •Patients who had scheduled both standard-of-care imaging (18F-FDG PET/CT) and 68Ga-MY6349 scans;
- •Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
- •No other anticancer therapy within four weeks prior to PET imaging.
排除标准
- •Patients with pregnancy or lactating;
- •Patients had a second primary tumor;
- •The inability or unwillingness of the research participant, parent, or legal representative to provide written informed consent.
研究组 & 干预措施
68Ga-MY6349
Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time.
干预措施: standard-of-care imaging (18F-FDG PET/CT), 68Ga-MY6349 PET/CT (Diagnostic Test)
结局指标
主要结局
Diagnostic performance (patient-based)
时间窗: 2 years
The patient-based sensitivity of 68Ga-MY6349 and standard-of-care imaging (18F-FDG PET/CT) were calculated and compared.
次要结局
- Diagnostic performance(2 years)
- SUVmax and TBR(2 years)
- Diagnostic performance (patient-based)(2 years)
- The impact on clinical management(2-4 weeks)
- Diagnostic accuracy(2 years)
- 68Ga-MY6349 safety(24 h)