Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System

  • STATUS
    Recruiting
Updated on 9 April 2019
cancer
stroke
transient ischemic attack

Summary

Background:

  • Researchers are testing version of a system known as a magnetic resonance imagining (MRI) scanner that uses strong magnetic fields, radio waves and the like to create images of the organs in the body. It uses lower energy levels than other MRI scanners. This may help scan people with metal devices in their body, or in invasive heart procedures using metal tools.

Objective:

  • To test a new MRI scanner and software changes to create better pictures.

Eligibility:

  • People with disease and healthy volunteers, ages 18 and older.

Design:

  • Participants will be screened with blood tests.
  • Participants may have both the new MRI and a conventional MRI or only the new one. If 2 are done, they must be within 60 days.
  • For both MRI versions, participants lie on a table that slides into a large tube. During scans, they will hold their breath for up to 20 seconds at a time. Heart activity will be measured by wires connected to pads on the skin. A flexible belt may be used to monitor their breathing. They will be in the scanner up to 2 hours.
  • Participants can agree to have a dye called gadolinium injected into their arm during the scan. This brightens the pictures.
  • Participants can agree to take a drug called a vasodilator. This helps detect areas of the heart with abnormal blood supply. Scans of the heart are taken before, during, and after they get the medicine. The drug may cause temporary chest pain or shortness of breath. They may get other drugs to relieve these symptoms.
  • Sponsoring Institution: National Heart, Lung, and Blood Institute

 

Description

Magnetic resonance imaging (MRI) generates medical images of organs inside the body and can provide accurate and reproducible measures of cardiac chamber volumes, cardiac function, blood flow, myocardial scar, extracellular volume as a measure of collagen content, iron content, and others, all without exposure to ionizing radiation. The prevailing wisdom is that MRI using high specific absorption rate (SAR) scanning modes produces highest image quality. We propose a method of MRI that can be performed with low SAR but that nevertheless preserves image quality because of efficient use of MRI signal. MRI using low SAR is attractive because it may reduce heating of metallic structures. This may allow safe MRI in patients with metallic implants, and it may allow MRI catheterization using metallic guidewires and catheter devices.

The goal of this non-significant risk (NSR) medical device study is to test initial technical feasibility of low SAR MRI in healthy volunteers by technical optimization of scanner protocols, to test comparative accuracy of standard CMR measurements in healthy volunteers using low SAR MRI versus conventional MRI.

A secondary goal is to assess the potential of this new low-SAR MRI system to perform cardiovascular diagnostic imaging and non-cardiovascular radiological diagnostic imaging by testing comparative diagnostic accuracy of standard MR measurements in adult patients with known disease using the low SAR MRI system vs conventional MR exam.

 

Details
Condition Cardiovascular Disease, *Healthy Patient Studies, Cardiovascular Imaging
Clinical Study IdentifierTX218180
Last Modified on9 April 2019

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women age >= 18 years
Able to provide informed consent in writing
Willingness to cooperate with all study procedures (including food restriction) and available for scheduled study events
Having known brain disease including but not limited to
Transient ischemic attack or stroke after 24 hours of onset
Infection, inflammation meningitis
Cognitive decline, neurodegenerative disorders
Demyelinating disease, multiple sclerosis
Loss of consciousness, seizures, epilepsy
Brain tumor, metastases, abscess, lesion
Vascular pathology
Headache
Hemorrhage
Trauma
Have known musculoskeletal disease including but not limited to
Persistent neck pain or radiculopathy
Cancer or tumors of the spine
Congenital abnormalities of the spinal cord or knee
Multiple sclerosis
Injury or trauma
Fracture evaluation
Infectious or inflammatory processes
Soft tissue damage
Muscle or tendon disorders
Knee meniscal disorders
Marrow abnormalities
Mechanical knee symptoms
Vascular conditions
Have known abdominal diseases including but not limited to
Bowel obstruction
Masses and tumors
Crohns disease
Diffuse liver disease such as hemochromatosis, hemosiderosis, fatty infiltration
Focal hepatic lesions
Cirrhotic liver
Iron content determination
Cystic kidney disease
Vascular abnormalities
Have known lung disease including but not limited to
Cancer, tumors and masses
Vascular and lymphatic abnormalities
Pulmonary thromboembolic disease
Trauma
Suspected bronchiolitis
Bronchiectasis or pneumonitis
Asthma and other obstructive lung diseases
Pulmonary lymphangioleiomyomatosis
Cystic and interstitial lung diseases such as pulmonary lymphangioleiomyomatosis and cystic fibrosis
Have other known non-cardiovascular disease

Exclusion Criteria

Acute illness for which investigational imaging might delay care (such as acute stroke before treatment), as determined by the enrolling physician
Any hemodynamic instability as determined by the enrolling physician
Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate form) including
Cardiac pacemaker or implantable defibrillator unless it is labeled MRI conditional or MRI safe
Cerebral aneurysm clip unless it is labeled safe for MRI
Neural stimulator (e.g. TENS-Unit) unless it is labeled safe for MRI
Any type of ear implant unless it is labeled safe for MRI
Ocular foreign body (e.g. metal shavings)
Metal shrapnel or bullet
Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe for MRI
Pregnancy. When uncertain, subjects will undergo serum pregnancy testing. Results from up to 7 days prior to the examination will be used. Post-menopausal and surgically sterilized subjects are exempt from this testing
Breast feeding in those subjects receiving contrast (unless subject is willing to discard breast milk for 24 hours)
When gadolinium based contrast agent (GBCA) exposure is planned
No gadolinium based contrast agent exposure is permitted if eGFR < 30 mL/min/1.73m using the CKD-EPI equation or equivalent and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications
Subjects meeting this exclusion criterion, or without eGFR determination, may still be included in the study but may not be exposed to gadolinium-based contrast agents
EXCLUSION CRITERIA FOR OXYGEN INHALTION
Severe chronic obstructive pulmonary disease defined as requiring more than one bronchodilator medication every day or oxygen requiring
Prior treatment with bleomycin
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