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临床试验/NCT04705467
NCT04705467招募中不适用

A Multi-Modality Comparison of Needle Placement During Gynecological Brachytherapy Procedures

Western University, Canada2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2022年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
35
试验地点
2
主要终点
Needle Localization Accuracy

研究概览

简要总结

Brachytherapy treatment in gynecological cancers is an essential component to delivering adequate doses of radiation to a tumour while sparing normal tissue. Interstitial or intra-cavitary brachytherapy are often needed in advanced or recurrent disease, in cases where intrauterine brachytherapy may not deliver the optimal outcome. Interstitial or intra-cavitary brachytherapy are based on a defined template-and-needle system, and the procedure relies on clinical examination and pre-treatment imaging to guide needle insertion. There is currently no standard image-guided process to help direct needles in the pelvis. We propose using 3D ultrasound to provide real-time imaging for the brachytherapy procedure, which will aid in avoiding needle insertion into pelvic organs and result in optimal dose coverage to the tumour.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Females of age eighteen (18) or greater.
  • Patients with locally advanced or recurrent gynecological malignancies who are offered interstitial or ring and tandem brachytherapy treatment. These typically would include patients with primary or recurrent vaginal cancers, endometrial cancers or cervical cancers. Histologies of these cancers are typically adenocarcinomas or squamous cell carcinomas

排除标准

  • Above patients who are not offered interstitial brachytherapy as a treatment modality

结局指标

主要结局

Needle Localization Accuracy

时间窗: 16 Months

Observed needle locations in 3-D TVUS and CT planning images are measured and compared.

次要结局

未报告次要终点

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Sponsor

研究点 (2)

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