Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer
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
研究组 & 干预措施
intracervical 18F-FDG injection during a dynamic PET/CT
The first 20 eligible patients will be consented to undergo intracervical 18F-FDG injection during a dynamic PET/CT scan. Study enrollment will occur in the clinic during the visit in which they are consented for surgery. Recruited patients will undergo 18F-FDG-guided PET imaging on the day of their scheduled staging surgery. The experimental PET/CT is anticipated to take 2 hours. The second stage of accrual will replace PET/CT with PET/MRI imaging. In every other aspect, patients will receive standard peri- and postoperative care.
干预措施: PET/MRI imaging (Device)
intracervical 18F-FDG injection during a dynamic PET/CT
The first 20 eligible patients will be consented to undergo intracervical 18F-FDG injection during a dynamic PET/CT scan. Study enrollment will occur in the clinic during the visit in which they are consented for surgery. Recruited patients will undergo 18F-FDG-guided PET imaging on the day of their scheduled staging surgery. The experimental PET/CT is anticipated to take 2 hours. The second stage of accrual will replace PET/CT with PET/MRI imaging. In every other aspect, patients will receive standard peri- and postoperative care.
干预措施: 18F-Fluorodeoxyglucose (18F-FDG) (Radiation)
intracervical 18F-FDG injection during a dynamic PET/CT
The first 20 eligible patients will be consented to undergo intracervical 18F-FDG injection during a dynamic PET/CT scan. Study enrollment will occur in the clinic during the visit in which they are consented for surgery. Recruited patients will undergo 18F-FDG-guided PET imaging on the day of their scheduled staging surgery. The experimental PET/CT is anticipated to take 2 hours. The second stage of accrual will replace PET/CT with PET/MRI imaging. In every other aspect, patients will receive standard peri- and postoperative care.
干预措施: PET/CT imaging (Device)
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)