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

NCT02995590 | Unknown Phase 1

• 1 other identifier: 19112
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Aim 1

  The difference between the deformation vector field derived from a given DIR algorithm (dDVF) and the known deformation vector field of the digital phantom (pDVF).

  At time of MRI

Secondary Outcomes (2)

• Aim 2

  At time of MRI

• Aim 3

  At time of MRI

Study Arms (1)

MRI of lung motion during breathing

EXPERIMENTAL

* 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.

Drug: Hyperpolarized He3

Interventions

Hyperpolarized He3 DRUG

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

Also known as: Helium study

MRI of lung motion during breathing

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Study Officials

• Yun M Shim, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roselove Asare, BSRT

CONTACT

434-243-6074; rnn3b@virginia.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 16, 2016
• Study Start: July 1, 2016
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2021
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)