Study on the Prediction of Groin Lymphonodal Status Through 18FDG-PET/CT Combined With Sentinel Lymph Node Biopsy in Bulky a/o Multifocal a/o Pretreated Vulvar Cancer, N0 at Conventional Imaging (GRO-SNaPET Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Accuracy and Negative Predictive Value of sentinel node biopsy in cN0 vulvar cancer patients that do not fit for the current indications
研究概览
简要总结
The study aim is to verify the accuracy of SNB combined with 18F-FDG PET/CT in cN0 invasive vulvar cancer (IVC) patients currently not candidate to SNB according to standard guidelines.
详细描述
Vulvar carcinoma (VC) is a rare disease (4% of gynecological cancers) and the treatment is not yet universally defined. No official guidelines are currently available to define imaging techniques useful for staging. In the pre-operative evaluation of the pateints, imaging should assess nodal status; the available exams are:
- CT or MRI with contrast (abdominal and pelvic with caudal scans for inguinal regions)
- Inguinal ultrasound with US-guided biopsy/fine needle aspiration for suspicious lymph nodes.
The incidence of inguinal and pelvic lymph node metastasis not diagnosed at the pre-operative imaging is 10-35% as assessed after lymphadenectomy at pathology report.
Until 2009, the standard surgical treatment of vulvar cancer was represented by mono or bilateral systematic lymphadenectomy (at least 70% of N0 women underwent a radical surgery with the risk of severe morbidity related to the surgical procedure with no survival benefit).
Inguinal lymphadenectomy shows a high rate of local and systemic complications resulting in a longer hospitalization or recovery, as well as possible delays in adjuvant therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age> 18 years
- •Adequate respiratory, hepatic, cardiac, bone marrow and renal function (creatinine clearance> 60 mL/min according to the Cockroft formula)
- •Patient psychologically able to follow the study procedures
- •Signature of informed consent
- •In addition, both major criteria and at least one of the minor criteria must be present:
- •MAJOR CRITERIA
- •Vulvar carcinoma (stromal infiltration > 1 mm); Histotypes different from squamous are included
- •Negative lymphnodes at preoperative imaging
- •MINOR CRITERIA
- •Vulvar lesion greater than 4 cm
- •Multifocal or bilateral lesions
- •Previous complete excisional biopsy of the vulvar lesion, with absent residual disease
- •Previous neoadjuvant treatment (radiotherapy a/o sequential/concomitant chemotherapy)
- •Previous treatment with radiotherapy a/o chemotherapy (sequential a/o concomitant) for previous vulvar cancer a/o other diseases
- •Previous vulvar or inguinal surgery
- •Infiltrating vulvar carcinoma with monolateral groin lymphnode involvement (N1) and contralateral N0
排除标准
- •Allergy to egg proteins and albumin
- •Pregnancy and breastfeeding
- •Patients with impaired respiratory, hepatic, cardiac, bone marrow and renal function (creatinine clearance> 60 mL / min according to the Cockroft formula)
- •Patients with major depressive disorder
研究组 & 干预措施
Vulvar cancer patients cN0 unfit for sentinel node biopsy
All invasive vulvar cancer patients with cN0 status:
- T > 4 cm;
- multicentric tumors (mono or bilateral);
- primary lesion completely excised during prior diagnostic surgery
- patients candidate to bilateral lymphadenectomy because of unilateral groin lymph node involvement, contralateral cN0
- previous radiotherapy a/o chemotherapy (sequential or concurrent). These patients are submitted to 18FDG PET/TC and sentinel node biopsy associated with standard preoperative imaging and radical groin lymphadenectomy
干预措施: 18FDG-PET/TC (Procedure)
Vulvar cancer patients cN0 unfit for sentinel node biopsy
All invasive vulvar cancer patients with cN0 status:
- T > 4 cm;
- multicentric tumors (mono or bilateral);
- primary lesion completely excised during prior diagnostic surgery
- patients candidate to bilateral lymphadenectomy because of unilateral groin lymph node involvement, contralateral cN0
- previous radiotherapy a/o chemotherapy (sequential or concurrent). These patients are submitted to 18FDG PET/TC and sentinel node biopsy associated with standard preoperative imaging and radical groin lymphadenectomy
干预措施: Sentinel node biopsy (Procedure)
结局指标
主要结局
Accuracy and Negative Predictive Value of sentinel node biopsy in cN0 vulvar cancer patients that do not fit for the current indications
时间窗: within the first 30 days after surgery
次要结局
- Accuracy and Negative Predictive Value of preoperative 18F FDG-PET/CT for the selection of cN0 patients.(within the first 60 days before surgery)
研究者
Prof. Giovanni Scambia
Professor
Catholic University of the Sacred Heart