Study Evaluation of Feasibility and Reproducibility of Investigational MRI Clinical Software
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
- 试验地点
- 3
- 主要终点
- Conduct clinical protocol development and validation
研究概览
简要总结
Patients and healthy volunteers will be scanned in order to test new sequences.
详细描述
The aims of this study are to:
- Conduct clinical protocol development and validation: The settings of an MRI machine are commonly adjusted according to the body part being scanned and the reason for the exam. When testing out new sequences and settings or adjusting existing settings, human subjects (patients and healthy volunteers) may be scanned in order to make sure that the quality of the images produced by the MRI machine is adequate for diagnostic purposes and to obtain normative values.
- Demonstrate and train: In some cases, human subjects may be scanned for the purposes of demonstrating equipment or for training operators on the safe and effective use of MRI systems.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• At least 18 years of age
- •Able to complete the MR safety questionnaire.
- •Able to comprehend and provide informed consent in English.
- •When contrast is being administered: healthy volunteers with a GFR≥60 ml/min
- •When contrast is being administered: patients with a GFR ≥30 ml/min
排除标准
- •• When contrast is being administered: subjects with a GFR < 30 ml/min
- •When contrast is being administered: subjects with acute kidney injury
- •When contrast is administered, allergy to gadolinium-containing contrast media
- •Contraindication to MRI (implanted device, claustrophobia, dyspnea precluding the ability to follow breath-hold instructions)
- •Adults unable to consent
- •Individuals who are not yet adults
- •Pregnant or breastfeeding women
- •Prisoners
研究组 & 干预措施
Patient w/ Contrast
Patients will add 15 minutes to their SOC MRI for research purposes
干预措施: MRI (Radiation)
Volunteer no contrast
Volunteers undergo 1 research MRI for research purposes
干预措施: MRI (Radiation)
Patient no contrast
Patients will add 15 minutes to their SOC MRI for research purposes
干预措施: MRI (Radiation)
Volunteer w/ contrast
Volunteers undergo 1 research MRI for research purposes
干预措施: MRI (Radiation)
Patient w/ Contrast
Patients will add 15 minutes to their SOC MRI for research purposes
干预措施: Gadavist 2Ml Solution for Injection (Drug)
Volunteer w/ contrast
Volunteers undergo 1 research MRI for research purposes
干预措施: Gadavist 2Ml Solution for Injection (Drug)
结局指标
主要结局
Conduct clinical protocol development and validation
时间窗: 5 years
Testing of new MRI pulse sequences will be performed for validation of potential new diagnostic capabilities. The MRI pulse sequences will be routinely performed along with clinically-validated and accepted pulse sequences for comparison of the novel sequences in human subjects (patients and healthy volunteers). Novel sequences will be performed in the accepted method with adjustment of settings to evaluate image qualities and normative values produced by the MRI machine. The resulting images provided by the novel sequences will be able to evaluated for diagnostic quality and to obtain comparison of possible improvements alongside clinically-validated MRI pulse sequences.
次要结局
- Demonstrate and train(5 years)
研究者
Ryan Avery
Associate Professor
Northwestern University