Development and Assessment of Individual 3D Printed Applicators in MRI Guided Gynecological Brachytherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- target volume CTV-HR
研究概览
简要总结
MRI guided adaptive brachytherapy (BT) represents the gold standard in the treatment of gynecological cancers. Commercially available standard MRI compatible applicators for BT of gynecological cancers don't always allow for optimal target volume coverage. Three-dimensional (3D) printed technology enables versatile possibilities of improvement of standard applicators and development of novel applicators with better coverage of the target volume. The purpose of this study is to implement and assess 3D printing technology as an instrument for designing and manufacturing applicators for individualized BT of gynecological cancers.
详细描述
Patients with locoregionally gynecological cancers will be included in this single-institution, non-randomized, one-arm study. All patients will receive 45-50 Gy external beam radiotherapy (EBRT) with intensity-modulated radiotherapy/volumetric-modulated arc therapy (IMRT/VMAT) technique, 1.8-2 Gy/fraction +/- concurrent cisplatin based chemotherapy. First BT with commercially available standard applicators (tandem with ring +/- parallel needles or vaginal cylinder) will be carried out. MRI with applicator in situ will be performed, high-risk clinical target volume (CTV-HR) and organs at risk (OAR) will be delineated and treatment planning will be conducted. In the case of large gynecological cancer and suboptimal target coverage at BT (V100 ≤ 90%, D98 ≤ 80%, D90 ≤ 100%, D100 ≤ 60%) a preplan will be performed as the basis for the 3D applicator modelling. The next BT application will be performed with an individually designed 3D printed applicator. Dose-volume characteristics of the following treatment plans will be compared: the preplan, the plan with standard and the plan with individual 3D printed applicator.
The primary objective of the study is to determine the improvement of dose-volume parameters with the use of 3D printed individual applicators in advanced gynecological 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with locally advanced gynecological cancer (cervical, uterine, vaginal, vulvar cancer) eligible for treatment with brachytherapy
- •squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma, histologically proven
- •patients fit for regional or general anesthesia
- •signed written informed consent
排除标准
- •regional or general anesthesia contraindications
- •contraindications for MRI
研究组 & 干预措施
Individualized 3D-Printed Brachytherapy Applicator
Participants with gynecological cancer and suboptimal target volume coverage using standard brachytherapy applicators receive MRI-guided brachytherapy using an individually designed 3D-printed applicator. Treatment plans generated with the standard and individualized applicators are compared within the same participant.
干预措施: Individualized 3D-Printed Brachytherapy Applicator (Device)
结局指标
主要结局
target volume CTV-HR
时间窗: at two hours after the end of brachytherapy procedure
V100 (%), D90 (%), D98 (%), D100 (%)
Improvement in High-Risk Clinical Target Volume Coverage
时间窗: During brachytherapy treatment planning, before delivery of the planned brachytherapy dose
Dose-volume parameters for the high-risk clinical target volume (HR-CTV) will be compared between treatment plans generated with a standard brachytherapy applicator and an individualized 3D-printed applicator within the same participant. Evaluated parameters include D90, D98, D100, and V100. The absolute and relative improvement achieved with the individualized applicator will be reported.
Number of Participants With Grade 3 or Higher Treatment-Related Toxicity
时间窗: From the first brachytherapy procedure through 60 months after completion of treatment
Treatment-related toxicity involving the bladder, rectum, bowel, and vagina will be assessed using the Common Terminology Criteria for Adverse Events, version 3.0. The number and percentage of participants with new or worsening grade 3 or higher toxicity will be reported. Vaginal stenosis will be evaluated separately in accordance with the study protocol.
次要结局
- organs at risk(at two hours after the end of brachytherapy procedure)
- Dose to Organs at Risk(During brachytherapy treatment planning, before delivery of the planned brachytherapy dose)
- Local Tumor Control(From completion of treatment through 60 months)