Clinical trial NCT03331302: Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy
Official title: Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: COPD patients with standard vs study diagnostic methods (imaging procedures)
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ventilation imaging resolution comparison between MRI and scintigraphy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia
name: Yun M Shim, MD
role: PRINCIPAL_INVESTIGATOR
References: