Comparison of 133Xe Scintigraphy With 19F MRI

NCT03532334 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: Pro00089045
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Diseases

Keywords

19F MRI gas Ventilation; 133 XE ventilation Scintigraphy

Outcome Measures

Primary Outcomes (1)

• Efficacy of 19F MRI compared to 133 Xenon Scintigraphy

  To evaluate the non-inferiority of 19F Perfluorinated gas MRI compared to 133 Xenon Scintigraphy ventilation imaging studies two readers will be selected as having experience reading Xe-133 ventilation scans. Readers will also receive training on interpretation of 19F ventilation images We note that the nature of the images both nuclear medicine and 19F MRI preclude blinding of the readers to the image modality. Images from each modality will be assessed independently and the images will be coded so that readers will not know which image set is from each subject.

  24 months

Interventions

Perfluorinated Gas/Oxygen Mixture DIAGNOSTIC_TEST

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

Also known as: Perfluorinated Propane Imaging

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients of either gender, age \> 18.
• Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed.)
• Women of childbearing potential must have a negative urine pregnancy test. This will be confirmed before participation in this investigational protocol.
• 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).

You may not qualify if:

• Subjects presenting with any of the following will not be included in the trial:
• \. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)

Sponsors & Collaborators

• Hal C Charles: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Cecil Charles, PhD

  Duke University Medical Center, Department of Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Radiology

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 22, 2018
• Study Start: April 4, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 24, 2018

Record last verified: 2018-07

Locations

US (1)