SENtinel Lymph Node Mapping With GAllium-68-tilmanocept PET/CT in High/High-intermediate Risk Endometrial Cancer: a Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Feasibility of 68Ga-tilmanocept PET/CT for SLN mapping
研究概览
简要总结
This pilot study evaluates the feasibility of 68Ga-tilmanocept PET/CT for SLN mapping in patients with endometrial cancer.
详细描述
Rationale: Currently, the use of indocyanine green (ICG) is the most widely accepted sentinel lymph node (SLN) mapping technique in endometrial cancer but the acquired SLN detection rates greatly vary. We propose that adding preoperative imaging with the radiotracer Gallium-68-tilmanocept (68Ga-tilmanocept) PET/CT can further improve SLN mapping in patients with endometrial cancer and reliably guide the surgeon towards the true SLN intraoperatively.
Objective: To evaluate the feasibility of sentinel lymph node imaging with 68Ga-tilmanocept PET/CT.
Study design: Non-randomised, single-centre, single-arm pilot study in the UMC Utrecht.
Study population: Patients with clinically stage I-II high/high-intermediate risk endometrial cancer scheduled for robot-assisted pelvic and para-aortic lymphatic staging (including SLN procedure). A total of 10 patients will be included.
Intervention (if applicable): Preoperative cervical injection of 68Ga-tilmanocept followed by preoperative PET/CT imaging (in adjunct to the standard-of-care: intraoperative injection with indocyanine green (ICG) with real-time near-infrared (NIR) fluorescence imaging). Injection of 68Ga-tilmanocept is performed by the gynaecologist in an outpatient setting. The PET/CT (PET + contrast enhanced CT abdomen) will be performed 30-90 minutes after tracer injection.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical FIGO 2012 stage I-II high/high-intermediate risk endometrial cancer;
- •Scheduled for robot-assisted full pelvic and para-aortic staging;
- •Age ≥18 years and able to provide informed consent.
排除标准
- •Pregnancy or current breastfeeding;
- •Prior severe allergic reaction to iodine;
- •Severe renal insufficiency (stage 3 or 4);
- •Clinical or radiological evidence of metastatic disease.
研究组 & 干预措施
68Ga-tilmanocept PET/CT
All participants receive 68Ga-tilmanocept PET/CT imaging in adjunct to standard-of-care (SLN mapping with intraoperative ICG).
干预措施: Gallium-68-tilmanocept (Drug)
结局指标
主要结局
Feasibility of 68Ga-tilmanocept PET/CT for SLN mapping
时间窗: One week post-PET/CT
Assessed by the SLN detection rate with 68Ga-tilmanocept PET/CT. Overall SLN detection rate is defined as the proportion of patients in which at least one SLN is detected. Bilateral SLN detection rate is defined as the proportion of patients with at least one SLN detected in each hemipelvis or para-aortic side.
次要结局
- Adverse events related to SLN mapping with 68Ga-tilmanocept PET/CT(Up to one hour post-PET/CT)
- Pathological status of SLNs(One week post-surgery)
- Correlation between SLN detection rate and anatomical location with preoperative 68Ga-tilmanocept PET/CT versus intraoperative ICG with near-infrared fluorescence.(Intraoperative)
研究者
Ronald Zweemer
Prof. dr. Ronald P. Zweemer
UMC Utrecht