Comparison of 133Xe Scintigraphy With 19F MRI

NCT ID: NCT03532334

Last Updated: 2018-07-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-04
• Study Completion Date: 2019-12-31

Brief Summary

The central hypothesis and current observation is that PFx gases used as contrast agents readily provide functional images of the lung airways including important regional ventilation information such as ventilation defect severity and gas trapping. This is a pilot proof of concept study to demonstrate the non-inferiority of 19F MRI gas Ventilation imaging compared to 133Xe ventilation Scintigraphy in subjects with lung disease. The secondary goal of the study is to develop sufficient information to adequately power a pivotal trial of 19F MRI gas Ventilation imaging compared to 133Xe Ventilation Scintigraphy

Detailed Description

Aim 1: Compare measures of lung ventilation performance obtained using 133Xe Scintigraphy with performance using 19F Perfluorinated gas MRI using two independent readers.

133Xe Scintigraphy will be scored using the methods described in the statistics section and 19F images will be scored using the methods described in the statistics section. Scores for each subject will be earluated for consistency between readers and modalities. 60% concordance will be considered equivalent.

The outcomes of the work proposed is expected to show the non-inferiority of 19F Perfluorinated gas MRI to 133Xenon Scintigraphy

Conditions

Lung Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

Perfluorinated Gas/Oxygen Mixture

19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, \< 1 hour

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Perfluorinated Propane Imaging

Eligibility Criteria

Inclusion Criteria

1. Outpatients of either gender, age > 18.

2. Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed.)

3. Women of childbearing potential must have a negative urine pregnancy test. This will be confirmed before participation in this investigational protocol.

4. Completion of 133Xe ventilation scintigraphy after referral for ventilation imaging for any reason in Pro00081987 A Comparison of Technegas® and Xenon 133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy. The MRI will be accomplished in a timely fashion after the Scintigraphy study based on scheduling availability in the Center for Advanced Magnetic Resonance Development (CAMRD).

Exclusion Criteria

Subjects presenting with any of the following will not be included in the trial:

1. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hal C Charles

OTHER

Sponsor Role: lead

Responsible Party

Hal C Charles

Assistant Professor of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Cecil Charles, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Center, Department of Radiology

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00089045

Identifier Type: -

Identifier Source: org_study_id