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Status:

ENROLLING_BY_INVITATION

Ultrahigh Field Body MR Imaging

Lead Sponsor:

University of Minnesota

Conditions:

Structure and Function of MRI

Eligibility:

All Genders

18-75 years

Brief Summary

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 he...

Eligibility Criteria

Inclusion

  • Healthy male or female volunteer over the age of 18

Exclusion

  • 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

Key Trial Info

Start Date :

February 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 31 2029

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT02236143

Start Date

February 1 2013

End Date

January 31 2029

Last Update

April 17 2025

Active Locations (1)

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1

University of Minnesota CMRR

Minneapolis, Minnesota, United States, 55455