Quantitative Assessment of Vaginal Tissue Response to Intravaginal Brachytherapy With Multiparametric Ultrasound Imaging (mpUS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 7
- 主要终点
- feasibility of B-mode ultrasound imaging
研究概览
简要总结
The researchers are doing this study to see how well multiparametric ultrasound (mpUS) imaging can evaluate vaginal tissue before and after IVRT. IVRT is routinely used to treat endometrial cancer but can cause damage to the vaginal tissue (vaginal toxicity). Side effects of vaginal toxicity can include vaginal dryness, itching, soreness, discharge, narrowing or shortening of the vagina (stenosis), and vaginal fibrosis (hardening), which can affect sexual function. The researchers will also look at whether participants are able to complete (tolerate) all mpUS imaging for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
This will be a prospective, single center clinical study with 10 patients with endometrial cancer to test the feasibility of using mpUS to characterize the vaginal tissue response to IVRT.
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
- •Patients must be diagnosed with a primary endometrial carcinoma. The following histologic subtypes are eligible for inclusion: endometrioid, serious, clear cell, dedifferentiated/undifferentiated, mixed epithelial, adenocarcinoma not otherwise specified, and carcinosarcoma
- •Initial surgical treatment must have included hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymph node assessment with either sentinel lymph node mapping/sampling or pelvic lymph node dissection. Surgical assessment of the para-aortic lymph nodes is not required
- •Patients must have had a complete surgical resection with negative margins and no residual gross disease after surgery
- •Patients must have FIGO (2009) stage I-II disease (per surgical staging)
- •Age ≥ 18 years
- •Patients must be able to start radiotherapy within 12 weeks from date of surgery
排除标准
- •Patients receiving chemotherapy or hormonal therapy
- •A prior or concurrent malignancy whose natural history or treatment would interfere with the toxicity or efficacy assessment of IVRT
- •Prior pelvic radiotherapy
- •Active genitourinary infection requiring antibiotics, except for uncomplicated urinary tract infection
- •History of active inflammatory bowel disease requiring treatment, including Crohn's disease and ulcerative colitis
- •Concurrent psychiatric or medical condition or disease which, per investigator judgement, would make them unsuitable candidates for study enrollment
研究组 & 干预措施
Multiparametric Ultrasound Imaging (mpUS)
All participants in this study will receive standard intravaginal brachytherapy (IVRT) and multiparametric ultrasound (mpUS) imaging right before IVRT, right after the last IVRT, and at 3, 6 and 12 months after IVRT.
干预措施: Multiparametric Ultrasound Imaging (Diagnostic Test)
Multiparametric Ultrasound Imaging (mpUS)
All participants in this study will receive standard intravaginal brachytherapy (IVRT) and multiparametric ultrasound (mpUS) imaging right before IVRT, right after the last IVRT, and at 3, 6 and 12 months after IVRT.
干预措施: The vaginal assessment score (VAS) (Other)
结局指标
主要结局
feasibility of B-mode ultrasound imaging
时间窗: 1 year
B-mode feasibility is defined as the ability to visualize/quantify vaginal wall thickness and echogenicity at baseline and immediately following the last IVRT treatment in 6 out of 10 patients.
次要结局
未报告次要终点