Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT03331302
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hyperpolarized Xenon-129 MRI (Experimental) — DRUG
    MRI ventilation scan of the lung with inhaled contrast agent (hyperpolarized Xenon-129)
  • Radioactive Xenon-133 scintigraphy (Active Comparator) — DRUG
    Radioactive ventilation scintigraphy of the lung with inhaled radioactive contrast agent (Xenon-133)

Study Details

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.

Key Dates

Start date
Sep 1, 2018
Status verified
Nov 2020
Primary completion
Jun 30, 2020
Completion
Dec 31, 2020

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

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)

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia Health SystemCharlottesvilleVirginia22908
Sarah Struchen, RN
434-243-6074
Roselove Nunoo-Asare, RT
434-243-6074
Mike Shim, MD (PRINCIPAL_INVESTIGATOR)

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