Recruiting
Phase 1

Hyperpolarized-gas MRI

Sponsor:

University of Virginia

Code:

NCT02995590

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

Hyperpolarized He3

Study Details

Brief summary:

Recently, the investigators have demonstrated a novel hyperpolarized helium tagging Magnetic Resonance Image (MRI) technique that is capable of directly, in vivo, and non-invasively measuring physiological lung deformation on a regional basis. This unique imaging technique holds great promise for assessing, validating, and improving the use of Deformable image Registration (DIR) algorithms in the lung. Our long term aim is to apply hyperpolarized gas tagging MRI to study lung biomechanics, develop more physiologically sound DIR algorithms for the lungs, and eventually improve radiotherapy of lung cancer. The overall aim of this application is to optimize the hyperpolarized helium tagging MRI technology and establish its usefulness for DIR assessment.

Our first objective is to develop and optimize a methodology based on 3 Dimensional (3D) hyperpolarized helium tagging MRI of healthy subjects, for directly measuring lung deformation between inhalation and exhalation. Our second objective is to develop physiologically sound digital thorax phantoms based on helium-3 tagging MRI of healthy subjects and demonstrate their use for DIR assessment in the lung. These phantoms will be used to evaluate a range different DIR algorithms, by comparing the errors between the DIR-derived deformation vector fields and the ground truth represented in the digital phantom. Successful completion of these aims will yield a novel methodology for DIR assessment in the lung for radiotherapy.

Conditions

Healthy Volunteers

Study ID

NCT02995590

Start date

Jul 1, 2016

Status verified date

Nov, 2020

Completion date

Dec 15, 2021

Anticipated

Primary completion date

Dec 15, 2019

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Inclusion Criteria:

  • All subjects must be willing to participate and undergo the procedure, and be manageable as out-patients.
  • Normal Subjects: Currently feeling well without respiratory symptoms.
  • No history of lung disease.
  • Never personally smoked (defined as less 100 cigarettes in their lifetime). -Secondhand smoke exposure is not an exclusion criterion.

Exclusion Criteria:

  • Blood oxygen saturation of less than 92% as measured by pulse oximetry on the day of imaging.
  • FEV1 percent predicted less than 80%.
  • Pregnancy or lactation.
  • Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded.
  • Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches.
  • History of congenital cardiac disease, chronic renal failure, or cirrhosis.
  • Inability to understand simple instructions or to hold still for approximately 10 seconds.
  • History of respiratory infection within 2 weeks prior to the MR scan
  • History of MI, stroke and/or poorly controlled hypertension.

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: MRI of lung motion during breathing

  • A medical history will be obtained defining any present and past history of respiratory illnesses, medications, and hospitalizations and the ability to have MR imaging.
  • A urine pregnancy test will be done for women of childbearing potential, who report the possibility that they might be pregnant.
  • Before and after MR imaging, a physical exam, spirometry, and a baseline %PO2 will be performed.
  • During the MR imaging procedure, the subject's heart rate and blood oxygen saturation will be monitored using an MR compatible pulse oximeter.
  • Once positioned in the MR scanner, conventional proton images of the thorax will be obtained to define the lung boundaries for subsequent image alignment. -Free breathing conventional MR imaging will be performed.
  • Hyperpolarized helium 3 imaging will be performed at breath hold.

Interventions

Hyperpolarized He3

Hyperpolarized Helium can be used as a Contrast Agent for Lung Images using MRI.

Primary outcome measure

  • Aim 1 [ Time Frame: At time of MRI ]

Central Contacts and Locations

Central contacts

Roselove Asare, BSRT

434-243-6074rnn3b@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Roselove Asare, RT

434-243-6074rnn3b@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Nov 4, 2020

Last verified

Nov, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2020-11-04.