Anti-1-amino-3-18F-flurocyclobutane-1-carboxylic Acid (Axumin) Positron Emission Tomography/Computed Tomography Prior to Retroperitoneal Lymph Node Dissection for Testicular Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Performance characteristics of Axumin PET scan in patients undergoing retroperitoneal lymph node dissection
研究概览
简要总结
Investigators will use Axumin PET/CT to help with the imaging modalities to determine the presence of occult retroperitoneal disease.
详细描述
Investigators aim to perform a prospective study of anti-18F-FACBC PET/CT in patients with NSGCT prior to RPLND, either in the primary setting or in the post-chemotherapy setting. We will correlate histopathologic outcomes from the RPLND specimen and clinical outcomes of recurrence during follow-up to identify the accuracy of anti-18F-FACBC PET/CT in these settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed NSGCT after orchiectomy who are scheduled to undergo primary RPLND or post-chemotherapy RPLND
- •Patients must be over 18 years old and capable and willing to provide informed consent.
- •Medically stable as judged by patient's physician.
- •Life expectancy must be estimated at > 6 months.
- •Patients must have an ECOG performance status of 0-3 (restricted to ECOG PS 0-2 if age >70 years).
- •Patient must be able to lie still for a 20 to 30 minute PET/CT scan. Patients will be asked if they have problems or issues with lying flat
排除标准
- •Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar chemical or biologic composition to anti-18F-FACBC are NOT eligible.
- •Patients with liver failure are NOT eligible.
- •Patients currently undergoing chemotherapy or chemotherapy within two weeks of anti-18F-FACBC PET/CT scan are NOT eligible
研究组 & 干预措施
Axumin PET scan
Only one arm is being evaluated--the arm receiving PET scan
干预措施: Axumin PET scan (Drug)
结局指标
主要结局
Performance characteristics of Axumin PET scan in patients undergoing retroperitoneal lymph node dissection
时间窗: Two years
Investigate the accuracy of anti-18F-FACBC PET/CT correlating with histopathologic outcomes
次要结局
未报告次要终点
研究者
yair lotan
Professor of Urology
University of Texas Southwestern Medical Center