Recruiting
Phase 1
Phase 2

Hyper Polarized Xenon-129 vs. Xenon-133

Sponsor:

University of Virginia

Code:

NCT03331302

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized Xenon-129 MRI (Experimental)

Radioactive Xenon-133 scintigraphy (Active Comparator)

Study Details

Brief summary:

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study ID

NCT03331302

Start date

Sep 1, 2018

Status verified date

Nov, 2020

Completion date

Dec 31, 2020

Anticipated

Primary completion date

Jun 30, 2020

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: COPD patients - Xe-133

COPD patients who will be assessed with Xenon-133 scintigraphy (Standard diagnostic study)

experimental: COPD patients - Hyperpolarized Xe-129

COPD patients crossed over from the Active Comparator Arm who will be assessed with hyper polarized Xenon-129 MRI (Experimental diagnostic study)

Interventions

Hyperpolarized Xenon-129 MRI (Experimental)

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

Radioactive Xenon-133 scintigraphy (Active Comparator)

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

Primary outcome measure

  • Ventilation imaging resolution comparison between MRI and scintigraphy [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Sarah Struchen, RN

4342436074SS8YM@hscmail.mcc.virginia.edu

Roselove Nunoo-Asare, RT

4342437363RNN3B@hscmail.mcc.virginia.edu

Locations

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Sarah Struchen, RN

434-243-6074SS8YM@hscmail.mcc.virginia.edu

Roselove Nunoo-Asare, RT

434-243-6074RNN3B@hscmail.mcc.virginia.edu

Principal Investigator:

Mike Shim, MD

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.