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NCT Number: NCT03331302

Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy

Hyper polarized Xenon-129 MRI will be directly compared to a radioactive Xe-133 scintigraphy to detect defects in lung ventilation from airflow limitation. This study is conducted as a pilot study with intention to conduct a larger clinical trial.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

About this study

Hyperpolarized Xenon-129 MRI has been developed by a number of techniques for imaging the lung that provide information about various aspects of lung function and structure. The main objective of this pilot study is to test and optimize the imaging parameters for a future industry sponsored clinical trial. The goal of the future trial is to determine the concordance between hyperpolarized xenon-129 ventilation MR imaging and nuclear medicine ventilation imaging (Gold Standard). In this study we will test the imaging parameters and techniques. We will directly compare human ventilation lung images in subjects with COPD, using nuclear medicine ventilation imaging with Xenon-133 gas scintigraphy versus hyperpolarized xenon-129 gas MRI. Our hypothesis is that current Xe-133 scintigraphy, which uses a radioactive gas (Xe-133) and produces a projection image of the lungs with relatively poor resolution, will not be able to detect small lung ventilation obstructions, which can be detected using hyperpolarized Xe-129 gas MRI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must have a diagnosis of COPD
  • at their clinical baseline on the day of imaging
  • must be clinically stable in order to participate in the study.
  • COPD subjects will be categorized according to the GOLD
  • Current/Former SmokerSubjects
  • must have a smoking history ≥ 10 pack years

Exclusion criteria

  • Dx of asthma
  • Continuous oxygen use at home
  • Blood oxygen saturation of 92% less than as measured by pulse oximetry on the day of imaging
  • FEV1 percent predicted less than 25%
  • 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.

Treatment and study plan

Hyperpolarized Xenon-129 MRI (Experimental)

Drug

MRI ventilation scan of the lung with inhaled contrast agent (hyperpolarized Xenon-129)

Other names: Polarean Pilot study

Radioactive Xenon-133 scintigraphy (Active Comparator)

Drug

Radioactive ventilation scintigraphy of the lung with inhaled radioactive contrast agent (Xenon-133)

Other names: Pilot study

Primary outcomes

  1. Ventilation imaging resolution comparison between MRI and scintigraphy

    Time frame: 12 months

    Compare the quality of the imaging between hyper polarized xenon-129 and radioactive xenon-133

Study contacts

Contact information is provided by the study sponsor or research team.

Roselove Nunoo-Asare, RT

CONTACT

[email protected]

4342437363

Sarah Struchen, RN

CONTACT

[email protected]

4342436074

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2017
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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