A Pilot Prospective Study of the Utility of Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI), Diffusion Weighted MRI (DWI)and Positron Emission Tomography (PET) Imaging With 18F-Fluorodeoxyglucose (18FDG) in Brachytherapy for Cervix Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Target delineation in brachytherapy using standard T2-weighted MRI versus DCE-MRI, DWI and FDG-PET/CT imaging: gross tumor volume and high-risk clinical target volume in patients with cervical cancer
研究概览
简要总结
The standard treatment for cervix cancer at Princess Margaret Hospital is external radiation with chemotherapy followed by internal radiation, called brachytherapy. Currently, brachytherapy treatment is planned on a type of Magnetic Resonance Imaging (MRI) called T2-weighted (T2W) MRI.
The main purpose of this study is to determine whether the following imaging tests can visualize the tumor better for planning the brachytherapy treatment:
- special types of MRI called diffusion weighted MRI (DWI) and dynamic-contrast enhanced MRI (DCE-MRI); and
- an x-ray test called positron emission test (PET) performed with a sugar dye called FDG. MRI-guided brachytherapy is resource-intensive and not widely available.
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
- •Age ≥ 18 years
- •Histologic diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix
- •FIGO Stage IB - IVA
- •Intention to treat using radiotherapy with or without concurrent cisplatin chemotherapy according to the current treatment policies of the PMH Gynecology Group
- •Intention to treat with MR-guided brachytherapy as part of standard radiotherapy according to the current treatment policies of the PMH Gynecology Group
- •No cytotoxic anti-cancer therapy for cervix cancer prior to study entry
- •A negative urine or serum pregnancy test within the two week interval immediately prior to the first PET-CT imaging, in women of child-bearing age
- •Ability to provide written informed consent to participate in the study
排除标准
- •Prior complete or partial hysterectomy
- •Carcinoma of the cervical stump
- •Inability to lie supine for more than 30 minutes
- •Insulin-dependent diabetes mellitus
- •Impaired kidney function with glomerular filtration rate < 30
- •Previous anaphylactic reaction to gadolinium or other contraindications to MR.
结局指标
主要结局
Target delineation in brachytherapy using standard T2-weighted MRI versus DCE-MRI, DWI and FDG-PET/CT imaging: gross tumor volume and high-risk clinical target volume in patients with cervical cancer
时间窗: 2 years
Target delineation using standard MRI acquired during the last week of EBRT fused to planning CT versus full MRI-guided brachytherapy.
时间窗: 2 years
This objective will evaluate the potential for translation of this technique to centres with limited MRI access.
次要结局
- Follow-up imaging (MRI and 18FDG PET) versus the imaging done at the time of brachytherapy(2 years)
- Imaging techniques for visualizing the brachytherapy applicator.(2 years)