NCT02285192进行中（未招募）1 期
Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 14
- 主要终点
- diagnostic accuracy of Positron Lymphography
研究概览
简要总结
The purpose of this study is to see if a radioactive substance called 18F-Fluorodeoxyglucose (18F- FDG), injected into the cervix during a PET/CT scan done before surgery can show us more clearly which lymph nodes in the pelvis (the area near your uterus and cervix) contain 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The study population will include women with stage IB1 cervical cancer (any histologic subtype) deemed eligible for surgery, and women with a clinical stage I high-grade endometrial cancer planning to undergo surgical staging. High grade is defined by the following:
- •Uterine serous carcinoma
- •Clear cell endometrial carcinoma
- •Grade 3 endometrioid carcinoma
- •Endometrial carcinosarcoma
- •Clinical stage I grade 1-2 endometrial cancer also eligible with deep myoinvasion ≥ 50% shown on preop MRI and/or elevated preop CA-125 > 35 U/ml.
- •Age ≥18 years
- •Hemoglobin ≥10 g/dL
- •Plasma albumin ≥3 g/dL
- •GOG performance status ≤2
- •Plasma glucose ≤200 mg/dL
- •Plasma creatinine ≤1.6
- •Well-controlled hypertension
- •Medical clearance for surgery and considered an appropriate surgical candidate
- •Negative serum pregnancy test, if of child-bearing potential
- •If, based on surgeon's assessment, the patient is recommended to undergo surgical staging for histologically confirmed endometrial cancer or if IB1 cervical cancer is deemed eligible for surgical treatment of disease
- •Participation in other research protocols does not exclude a patient from participation in this study
排除标准
- •Hemoglobin <10 g/dL
- •Plasma albumin <3 g/dL
- •GOG performance status >2
- •Plasma glucose >200 mg/dL
- •Renal insufficiency with plasma creatinine >1.6
- •Uncontrolled hypertension
- •Patient does not meet medical clearance for surgery and is not considered an appropriate surgical candidate
- •Pregnancy
- •For Stage 2:
- •Patient who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers of non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc.
- •Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI
结局指标
主要结局
diagnostic accuracy of Positron Lymphography
时间窗: 2 years
Accuracy of Positron Lymphography will be defined in terms of sensitivity and will consist of pathology review of labelled, excised specimens compared with lymph node imaging data acquired preoperatively.
次要结局
- to evaluate several standard uptake value (SUV) (18F-FDG avidity)(2 years)
研究者
研究点 (14)
Loading locations...
相似试验
已完成
不适用
PET-FDG in MyocarditisMyocarditisViral MyocarditisNCT03777839Montreal Heart Institute25
已完成
不适用
Performance of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Diagnosis of Indeterminate Adrenal Tumors on Conventional Imaging: A French Prospective Multicentric StudyAdrenal TumorsNCT01284829Assistance Publique Hopitaux De Marseille87
已完成
不适用
Combined FDG PET/CT Imaging in Response Evaluation After Radiochemotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)Locally Advanced Squamous Cell Carcinoma of the Head and Neck RegionNCT01179360University Hospital, Antwerp152
Unknown
不适用
18F-FDG PET/CT and Molecular Tumor Characterisation for Staging and Follow-up of Colon CancerColon CancerNCT01636674Naestved Hospital66
已完成
1 期
Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED)Atherosclerotic Vascular DiseaseNCT00703261Merck Sharp & Dohme LLC83