Head-to-head Study of 68Ga-MGS5 Versus 68Ga-DOTATATE PET/CT in Patients With Medullary Thyroid Carcinoma: a Prospective Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- SUVmax and SUVpeak
研究概览
简要总结
Cholecystokinin-2 (CCK2) receptor is overexpressed in more than 90% of MTC cases, and preclinical studies have shown that 68Ga-MGS5 (targeting CCK2) has good stability in vivo and is promising for diagnosis and staging of MTC. This prospective study will compare the diagnostic effects of 68Ga-MGS5 and 68Ga-DOTATATE on MTC primary foci, lymph node metastasis, and distant metastasis, and explore the effect of 68Ga-MGS5 PET/CT on the clinical staging (TNM staging) of MTC.
详细描述
This study was planned to enroll 20 patients with suspected MTC and MTC recurrence who attended the First Hospital of Fujian Medical University from June 2023 onwards. Each patient completed PET/CT examination within 1 week, one 68Ga-DOTATATE PET/CT whole-body examination and two 68Ga-MGS5 PET/CT whole-body examinations (1 hour and 2 hours after injection, respectively). CCK2 immunohistochemical staining and expression scoring of primary foci and lymph node metastases were also performed.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either gender, aged ≥ 18 years and ≤80 years.
- •Patients with pathologic findings confirming the diagnosis of MTC
- •Patients with MTC recurrence
- •Signed written consent
排除标准
- •Pregnant or breastfeeding female patients
- •Patients with claustrophobic behavior
- •The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent
研究组 & 干预措施
Patients will undergo a 68Ga-MGS5 PET/CTF and 68Ga-DOTATATE PET/CT
MTC Patients received 68Ga-DOTATATE PET/CT imaging and a single injection of 68Ga-MGS5 and two PET/CT scans 1 hour and 2 hours after the injection within one week.
干预措施: 68Ga-MGS5 (Drug)
结局指标
主要结局
SUVmax and SUVpeak
时间窗: through study completion, an average of 2 years
Determination of SUVmean and SUVpeak for detected lesions and discernible organs of 68Ga-MGS5 and 68Ga-DOTATATE scan.
次要结局
- immunohistochemistry(through study completion, an average of 2 years)
研究者
Weibing Miao, PhD
Director, Department of Nuclear Medicine
First Affiliated Hospital of Fujian Medical University