Assessing Deformable Image Registration in the Lung Using Hyperpolarized-gas MRI

Status unconfirmed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT02995590

Run by

University of Virginia

People needed

24

Starts

2016-07-01

Expected to finish

2021-12-15

Last updated by the study team

2020-11-04

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Virginia — Charlottesville, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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