Ultrahigh Field Body MR Imaging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Structure and Function of MRI. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The primary objective of this study is to develop new ways to acquire MRI data and/or new ways to analyze the acquired data.
Detailed description
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.
Primary outcome measures
- Structure and Function of MRI [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- Healthy male or female volunteer over the age of 18
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- University of Minnesota CMRR — Minneapolis
Identifiers
NCT: NCT02236143 · 1212M24883