A Clinical Trial to Evaluate Image-Guided Gynecologic Brachytherapy in the Advanced Multimodality Image-Guided Operating Suite (AMIGO)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Mean Doses Given
研究概览
简要总结
Standard therapy for gynecologic cancers involves the use of brachytherapy, also called internal radiation therapy or implant radiation. The treatment being studied consists of standard brachytherapy with the additional use of MRI to guide the insertion of radioactive applicators. The purpose of the study is to find out whether MRI-guided brachytherapy is practical and beneficial when compared to the standard CT-guided brachytherapy placement. The investigators are hoping that this MRI procedure will decrease the risk of giving too high a radiation dose to the bladder or bowel.
详细描述
The insertion of the brachytherapy applicator will be administered in the Advanced Multimodality Image-Guided Operating (AMIGO) suite at Brigham and Women's Hospital. Subjects will undergo an MRI scan in the AMIGO suite ensuring proper placement of the applicator. Subjects may have an optional FMISO-PET scan.
Subjects will have a follow-up visit including physical exam, pap smear, and MRI of the pelvis and/or PET scan 90 days after treatment.
Subjects will have a follow-up visit including physical exam, pap smear, and MRI of the pelvis and/or PET scan 180 days after treatment.
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
- •Histologically or cytologically confirmed carcinoma of the cervix (Stage I-IVA), carcinoma of the uterus (Stage IIIB), carcinoma of the vagina (Stage I-IVA), or carcinoma of the vulva (stage I-IVA)
- •Life expectancy > 6 months
- •MRI of the pelvis and/or PET-CT within 4 months prior to entering study
排除标准
- •Uncontrolled intercurrent illness
- •Pacemaker, brain aneurysm clip, inner ear implant, neurostimulator, or metal fragments in the eye
研究组 & 干预措施
Image-Guided Brachytherapy
Image-guided brachytherapy
干预措施: Image-guided brachytherapy (Procedure)
Image-Guided Brachytherapy
Image-guided brachytherapy
干预措施: 3'-Deoxy-3'-18f-Fluorothymidine (Drug)
结局指标
主要结局
Mean Doses Given
时间窗: Measured while on treatment, up to 2 months.
Doses given to the tumor, rectum, and sigmoid obtained after AMIGO-guided placement.
次要结局
未报告次要终点
研究者
Martin King, MD, PhD
Prinicipal Investigator
Dana-Farber Cancer Institute