Acquisition of Trans-Rectal Ultrasound [TRUS] Images of the Female Pelvis for Real-Time MRI-US Fusion Based Needle Tracking for Image-Guided Brachytherapy: A Pre-feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of patients whose MRI and ultrasound images are fused
研究概览
简要总结
The purpose of this study is to utilize transrectal ultrasound (TRUS) images of the intact and post-hysterectomy female pelvis in order to provide feasibility information for a Magnetic Resonance Imaging (MRI)-TRUS fusion based 3D needle navigation system for use in image guided brachytherapy. The fusion and needle guidance will be performed using Eigen Health's navigation system that currently provides targeted MR/Ultrasound fusion based prostate biopsies utilizing a proprietary 3D semi-robotic navigation system.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven invasive primary squamous, adenosquamous, or adenocarcinoma of the uterine cervix, (recurrent or medically inoperable) uterine adenocarcinoma.
- •Treatment plan must include curative-intent definitive radiation that includes brachytherapy treatments with or without concurrent chemotherapy
- •Adults ≥ 18 years of age
- •ECOG Performance Status 0-2
排除标准
- •Patients with active rectal bleeding or rectal ulcer
研究组 & 干预措施
Intact anatomy
Patients with intact anatomy (uterus and cervix)
干预措施: Transrectal ultrasound (TRUS) (Other)
Post-hysterectomy
Post-hysterectomy patients (vaginal cuff) who are planned to receive brachytherapy
干预措施: Transrectal ultrasound (TRUS) (Other)
结局指标
主要结局
Number of patients whose MRI and ultrasound images are fused
时间窗: up to 5 weeks
次要结局
未报告次要终点