A Novel Imaging Modality to Evaluate Radiation-Induced Uterine Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- SWE feasibility
研究概览
简要总结
The goal of this pilot study is to assess the ability of a new imaging modality, shear-wave-elastography (SWE) and magnetic resonance imaging (MRI) to identify radiation-induced uterine injury (RIUI). The investigator will recruit female patients treated before 40 years with pelvic radiation (PRT) at least 12 months prior to study initiation.
详细描述
The investigator will recruit female patients treated before 40 years with pelvic radiation (PRT) at least 12 months prior to study initiation.12 months is selected to increase the occurrence of uterine fibrosis. The investigator will perform transabdominal standard B-mode and Doppler US, SWE and pelvic MRI and characterize uterine parameters. The B-mode and Doppler US will be referred to collectively as US. This will provide essential information to design an intervention trial of a novel therapeutic approach to the treatment of radiation-induced uterine damage. The overall objective of the study will be achieved through the following specific aims:
Aim 1: Assess the feasibility of SWE and pelvic MRI to identify and characterize uterine fibrosis. Hypothesis: A grid map sampling of the uterus will indicate feasibility of SWE and pelvic MRI to detect and characterize uterine fibrosis.
Approach: SWE and MRI will be performed at time of study recruitment. US procedures will be transabdominal. When possible, and with participant consent, transvaginal US will also be performed. MRI images will also be sampled from existing pretreatment studies performed as standard of care.
Perform SWE and MRI sampling of the uterus from fundus to lower uterine segment at two locations each from the upper, mid, and lower thirds of the uterus (six grid sample locations).
Obtain five measurements at each location to evaluate for the presence and degree of fibrosis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Less than 40 years old "at the time of pelvic radiation"
- •≥ 18 and < 45 years of age "at time of enrollment"
- •Treated with PRT at UCH
- •Pelvic MRI taken before the pelvic radiation
排除标准
- •Patients who underwent hysterectomy for treatment of a primary gynecologic malignancy
- •Patients that are currently pregnant
研究组 & 干预措施
Cases undergone PRT
Patients (or their legal guardians) who opt for participating in this pilot study will be consented and enrolled in the study. Patients will then be scheduled for a single study visit at the University of Colorado Hospital (UCH) that includes:
- Pregnancy test
- Pelvic MRI without and with contrast (if patient consents to contrast)
- Transabdominal pelvic ultrasound using standard B-mode and Doppler US, SWE
- Optional transvaginal ultrasound using standard B-mode and Doppler US, SWE
干预措施: MRI, SWE, and US evaluation (Diagnostic Test)
Controls
Controls (or their legal guardians) who opt for participating in this pilot study will be consented and enrolled in the study. Patients will then be scheduled for a single study visit at the University of Colorado Hospital (UCH) that includes:
- Pregnancy test
- Pelvic MRI without and with contrast (if patient consents to contrast)
- Transabdominal pelvic ultrasound using standard B-mode and Doppler US, SWE
- Optional transvaginal ultrasound using standard B-mode and Doppler US, SWE
干预措施: MRI, SWE, and US evaluation (Diagnostic Test)
结局指标
主要结局
SWE feasibility
时间窗: Up to six months
SWE will be considered feasible if at least 85% (e.g., ≥15/17) of all patients achieve the diagnosability criteria, defined as having at least 1 of 6 locations with IQR/M ≤ 30%. The IQR/M and the number of patients who achieved diagnosability will be descriptively characterized.
Compare the degree of fibrosis according to SWE and MRI parameters across treatment groups
时间窗: Up to six months
Since fibrosis thresholds have not been thoroughly established for SWE tissue stiffness nor MRI parameters, continuous SWE tissue stiffness (kPA) will be compared separately to each MRI parameter: uterus size, junctional anatomy, endometrial thickness, cervical length, myometrial thickness, T2 signal, and enhanced features.
Evaluate the correlation between MRI images collected at pretreatment and after recruitment, using repeated measures correlation.
时间窗: Up to six months
Descriptive statistics and previously described figures will be similarly used to characterize the change in each MRI parameter between the pre-treatment and post-treatment timepoints. Additionally, linear mixed effects regression models will be performed separately with each MRI parameter. The predictors will include pre- and post- treatment time points and treatment group. If appropriate, radiation dose will be included in the model as well, where the radiation dose will be assigned as 0 for the control patients. Contrast statements will be used to assess the change in each outcome comparing treatment groups and the radiation doses effect.
次要结局
- Characterize uterine parameters after PRT(Up to six months)