Ultrahigh Field Body MR Imaging



Status:Enrolling by invitation
Healthy:No
Age Range:18 - 75
Updated:11/29/2017
Start Date:February 2013
End Date:June 2018

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The primary objective of this study is to develop new ways to acquire MRI data and/or new
ways to analyze the acquired data.

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.

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:

1. 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.

2. If they are claustrophobic and to rate the severity.

3. If they wear hearing aids and if they can be removed for the scan.

4. If they have a transdermal delivery system, and if yes where is it located and if
it can be removed for the study.

5. If they wear colored contact lenses and, if yes, can they be removed for the
study.

6. To provide a list of medications, dosages and time of last dose for medicines
taken regularly.

7. To identify if they have any pre-existing medical conditions including
Hypertension, Hypotension, Diabetes, Cardiovascular Disease and Fever.

8. To identify if they ever had an operation.

9. To indicate if they have ever been injured by a metallic foreign body which was
never removed.

10. If they wear braces and/or if they have removable bridgework, false teeth or a
permanent retainer.

11. If they have any tattoos, non-removable body piercings or hair extensions.

12. If they are currently using/wearing an IUD or diaphragm.

13. 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
We found this trial at
1
site
Minneapolis, Minnesota
?
mi
from
Minneapolis, MN
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