NCT02236143Enrolling By Invitation不适用
Ultrahigh Field Body MR Imaging
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Structure and Function of MRI
研究概览
简要总结
The primary objective of this study is to develop new ways to acquire MRI data and/or new ways to analyze the acquired data.
详细描述
The acquired data will be used to investigate the structure and function of the body. In addition the developmental aspect of this study, certain information may be used to obtain normal values for healthy adult structural and functional information. This information would be valuable if and when the developed methods are incorporated into future clinical studies involving patient populations which would be recruited under separate protocols. Our hypotheses is that imaging and spectroscopy methods can be developed to a level where the increased sensitivity and resolution of 7 Tesla (7T) MRI will improve the non-invasive studies of the human body.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female volunteer over the age of 18
排除标准
- •Exclusion criteria include those associated with the use of MR as the imaging modality. The specific set of exclusion criteria for a given study will depend on the specific study to be performed which will be made clear on initial contact and during consent. In addition, other medical conditions deemed by the PI or associates to make the patient ineligible for protocol procedures may also arise.
- •Exclusion criteria will be assessed during a safety screening interview and during final consent. A questionnaire will be provided regarding general health and exclusion/inclusion criteria. The investigator doing the interview will determine if any of the exclusion criteria apply. Subjects will be asked:
- •To describe any previous surgeries to help subjects and study staff open a dialogue as to any possible contraindications listed in the yes/no section below.
- •If they are claustrophobic and to rate the severity.
- •If they wear hearing aids and if they can be removed for the scan.
- •If they have a transdermal delivery system, and if yes where is it located and if it can be removed for the study.
- •If they wear colored contact lenses and, if yes, can they be removed for the study.
- •To provide a list of medications, dosages and time of last dose for medicines taken regularly.
- •To identify if they have any pre-existing medical conditions including Hypertension, Hypotension, Diabetes, Cardiovascular Disease and Fever.
- •To identify if they ever had an operation.
- •To indicate if they have ever been injured by a metallic foreign body which was never removed.
- •If they wear braces and/or if they have removable bridgework, false teeth or a permanent retainer.
- •If they have any tattoos, non-removable body piercings or hair extensions.
- •If they are currently using/wearing an IUD or diaphragm.
- •If they have any reason to believe they are pregnant. (If the subjects are unsure about their pregnancy status, test kits will be available to subjects).
- •In addition, a set of yes/no questions will be asked in the screening form for the patient to confirm or deny the presence of items that may be hazardous to their safety and/or some interfere with the MRI examination, including:
- •No Cardiac pacemaker
- •No Implanted cardiac defibrillator
- •No Carotid artery vascular clamp
- •No Intravascular stents, filters, or coils
- •No Aortic clip
- •No Internal pacing wires
- •No Vascular access port and/or catheter
- •No Swan-Ganz catheter
- •No Shunt (spinal or intraventricular)
- •No Aneurysm clip(s)
- •No Neurostimulator
- •No Electrodes (on body, head, or brain)
- •No Heart valve prosthesis
- •No Any type of prosthesis (eye, penile, etc.)
- •No Artificial limb or joint replacement
- •No Bone growth/fusion stimulator
- •No Bone/joint pin, screw, nail, wire, plate
- •No Metal rods in bones
- •No Harrington rods (spine)
- •No Metal or wire mesh implants
- •No Wire sutures or surgical staples
- •No Insulin pump or infusion device
- •No Any metal fragments (i.e. metal shop)
- •No Any implant held in place by a magnet
- •No Cochlear, otologic, or ear implant
研究组 & 干预措施
MRI
Subjects undergoing MRI
结局指标
主要结局
Structure and Function of MRI
时间窗: Baseline
Validate MRI measurement
次要结局
未报告次要终点
研究者
研究点 (2)
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