Development and Assessment of Individual 3D Printed Applicators in MRI Guided Gynecological Brachytherapy
概览
- 阶段
- 不适用
- 干预措施
- 3D printed applicator
- 疾病 / 适应症
- Cancer
- 发起方
- Institute of Oncology Ljubljana
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- target volume CTV-HR
- 状态
- 已完成
- 最后更新
- 2个月前
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.
研究者
入排标准
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
3D printed applicator
individually designed applicator for BT
干预措施: 3D printed applicator
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 (%)
次要结局
- organs at risk(at two hours after the end of brachytherapy procedure)