Prospective Observational Study on Sentinel Node Biopsy Using Two Concurrent Labelling Techniques (Radioactive Tracer With/Without Blue Dye vs. Indocyanine Green-ICG) in Early-stage Endometrial Cancer Patients (TESLA-1).
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 83
- 试验地点
- 11
- 主要终点
- SLN unilateral detection rate
研究概览
简要总结
Sentinel lymph node (SLN) biopsy is currently used in the management of vulvar and breast cancers as well as in malignant melanoma, and is being intensively studied in patients with cervical and endometrial cancers. The role of lymphadenectomy in the surgical management of early-stage endometrial cancer is still controversial. The main reason to perform a SLN biopsy is to detect the lymph node that will be the first involved with metastatic disease in the nodal basin. The SLN biopsy is performed after the SLN is located with the use of different tracers in a concept called SLN mapping. Moreover, SLN evaluation has been reported to improve the accuracy of lymph node staging due to SLN pathologic ultrastaging, which includes multiple serial sectioning and immunohistochemical assessment. The aim of this project is to conduct a multicentre, prospective, observational trial to compare two different SLN labelling methods (radioactive tracer with/without blue dye vs. indocyanine green-ICG) in the same patient and to evaluate the unilateral detection rate, sensitivity, number of detected SLN, anatomical localisation of detected SLN and bilateral detection rate of SLN. The main aim of the trial is the comparison of SLN mapping between two SLN labelling methods in the same patient. The trial will answer a question whether a combination of labelling methods in the same patient increase importantly the sensitivity of SLN biopsy.
The trial has a high potential to reach the calculated number of cases and thus bring in evidence/data that will be essential for future management of SLN biopsies in endometrial cancer.
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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven endometrial cancer (any tumour type).
- •Apparent early-stage endometrial cancer with intermediate or high risk prognostic factors (deep myometrial invasion or G2/G3 disease or non- endometrioid histological type), no evidence of bulky or suspicious pelvic/para-aortic lymph nodes or distant metastases on preoperative conventional imaging studies; minimum requirement for clinical staging includes expert US or pelvic MRI for local staging and abdominal US or abdominal CT scan or PET CT for distant staging.
- •Performance status ECOG: 0-
- •Age ≥18, ≤
- •History of second primary cancer only if more than 5 years with no evidence of disease.
- •Approved and signed informed consent form to participate in the study.
排除标准
- •Pregnancy
- •Desire for fertility sparing
- •History of pelvic or abdominal radiotherapy
结局指标
主要结局
SLN unilateral detection rate
时间窗: 2 years
Number of hemipelvises where the SLN was found/number of all hemipelvises for each tracer and combination of tracers
次要结局
- Bilateral detection rate.(2 years)
- Sensitivity of SLN biopsy for pelvic lymph node staging. Anatomical localisation of detected SLN(2 years)
- Number of detected SLN.(2 years)
- Descriptive meassure: Anatomical localisation of detected SLN(2 years)
研究者
Maja Pakiz
Dr.
University Medical Centre Maribor