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Comparison of 129Xe MRI With 19F MRI in CF Lung Disease

NCT03482960 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-01-25

No results posted yet for this study

Summary

This study is designed to compare the capabilities of two novel imaging techniques: polarized perfluorinated gas mixed with oxygen, and hyperpolarized xenon mixed with N2 to detect changes in lung ventilation using MRI.

Conditions

Interventions

DRUG

Hyperpolarized Xenon gas

Hyperpolarized Xenon gas * Hyperpolarized mixture (750ml HP 129Xe and 250ml nitrogen) * Administration: By mouthpiece attached to a single use Tedlar bag. * Dosage: 750 mL of the 129Xe mixture up to, but not exceeding, four doses of the 129Xe. * Frequency: 10-minute interval between doses.

DRUG

PFP

* Inhaled PFP, a gaseous contrast agent (79% PFP; 21% O2, pre-mixed, medical grade gas) * Administration: Full-face disposable ventilation mask and a standard Douglas Bag system. * Dosage: Two controlled breaths of the contrast gas followed by a full breath and a 12-second breath-hold and scan for image acquisition. * Frequency: Repeated 5 times followed by an identical five cycles with room air to ensure PFP gas wash-out has occurred.

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Jennifer Goralski, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-29
Primary Completion
2019-04-09
Completion
2019-04-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03482960 on ClinicalTrials.gov