Rapid Motion-Robust Quantitative DCE-MRI For The Assessment Of Gynecologic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- assess changes in Ktrans value
研究概览
简要总结
This study will test a new type of DCE (dynamic contrast-enhanced) MRI (magnetic resonance imaging) to see whether, compared with traditional MRI, it produces better images that provide more information about tumors, which may help doctors make better decisions about treating women who have gynecologic cancer.
MRI is commonly used to detect and evaluate many types of cancer, but its slow processing speed and the risk that images will be blurred if the patient moves inside the scanner can limit its use in clinical practice. DCE MRI is a new imaging technique that uses additional computer processing to collect information continuously during scanning, which produces more detailed images faster than traditional MRI, which reduces the risk of movement-related blurring and provides important information about tumor activity.
The DCE MRI scan in this study will be done in a standard MRI scanner, using a contrast agent (gadobutrol; Gadavist®) that has been approved by the FDA.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers (for SA1) will be entered into the study if they meet the following criteria:
- •Women aged 18 years or older.
- •Willing and able to provide informed consent
- •Patients (for SA2) will be entered into the study if they meet the following criteria:
- •Women aged 18 years or older.
- •Gynecologic cancer undergoing standard of care pelvic MRI prior to treatment
- •Willing and able to provide informed consent and adhere to the study visit schedule and plan as specified in this protocol.
排除标准
- •Healthy volunteers (SA1) and patients (SA2) exclusion criteria:
- •History of allergic reactions to gadolinium-based contrast agents (GBCAs)
- •Women of childbearing potential (WOCBP) must not be pregnant.
- •Women must not be breastfeeding.
- •Contraindications/risk factors to 3T MRI as per assessed by our departmental "Comprehensive MRI Screening Questionnaire" and "MRI Contrast Dye Questionnaire" (e.g. risk factors associated with magnetic field such as cardiac pacemakers, defibrillators or other devices as per standard institutional policy; and risk factors associated with GBCM such as diabetes, dialysis, breastfeeding)
研究组 & 干预措施
DCE-MR images with Gadobutrol (GBCA)
All subjects will be imaged on the same 3T MRI scanner (GE Healthcare, USA) at MSK for all examinations. For SA1, subjects will undergo a single research DCE-MRI exam. Patients in SA2 will undergo a standard of care pelvic MRI at baseline (which includes DCE-standard) in accordance with standard clinical operating procedures at MSK. All DCE imaging will be performed after the intravenous injection of the GBCA Gadobutrol (Gadavist, Bayer Healthcare) at 0.1 mL/kg body weight (0.1 mmol/kg), administered as a bolus at a flow rate of approximately 2 mL/s.
干预措施: Gadobutrol (Drug)
DCE-MR images with Gadobutrol (GBCA)
All subjects will be imaged on the same 3T MRI scanner (GE Healthcare, USA) at MSK for all examinations. For SA1, subjects will undergo a single research DCE-MRI exam. Patients in SA2 will undergo a standard of care pelvic MRI at baseline (which includes DCE-standard) in accordance with standard clinical operating procedures at MSK. All DCE imaging will be performed after the intravenous injection of the GBCA Gadobutrol (Gadavist, Bayer Healthcare) at 0.1 mL/kg body weight (0.1 mmol/kg), administered as a bolus at a flow rate of approximately 2 mL/s.
干预措施: MRI (Diagnostic Test)
结局指标
主要结局
assess changes in Ktrans value
时间窗: 48 hours
Each MRI sequence will have a DCE-MRI quantitative metric Ktrans value for each of 2 independent readers. The Ktrans value will be generated from the ROIs placed independently by each radiologists using dedicated software
assess changes in Ktrans value
时间窗: baseline
Each MRI sequence will have a DCE-MRI quantitative metric Ktrans value for each of 2 independent readers. The Ktrans value will be generated from the ROIs placed independently by each radiologists using dedicated software
次要结局
未报告次要终点