Lung Transplant Subjects Using 19F MRI

NCT02019251 | Completed Phase 1 DMC

• 2 other identifiers: Pro00047929DIAL1001005
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the utilization of conventional 'thermally' polarized perfluorinated gases mixed with oxygen as inhaled inert contrast agents to image the airway spaces in subjects who have undergone single or double lung transplantation. This is an open label study expanding on current work here at Duke. Images will be obtained using 19F MRI during wash-in and washout for evaluation of ventilation efficiency.

Conditions

Post Single or Double Lung Transplant

Outcome Measures

Primary Outcomes (1)

• obtain regional, non-invasive images of pulmonary function in patient's post lung transplantation

  1 day (Single exposure)

Study Arms (1)

Post single or double lung transplant

EXPERIMENTAL

The subjects will receive the gas by breathing perfluorinated gas/oxygen mixture using Disposable Face mask and a standard Douglas Bag system.

Drug: perfluorinated gas/oxygen mixture; Device: MRI

Interventions

perfluorinated gas/oxygen mixture DRUG

Subjects are imaged with MRI one time with the use of perfluorinated gas / oxygen mixtures as an MRI contrast agent for lung function.

Post single or double lung transplant

MRI DEVICE

Post single or double lung transplant

Eligibility Criteria

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

You may qualify if:

• Subjects must be ≥ 18 years of age;
• Post single or double lung transplant;
• Subjects who are willing and able to comply with scheduled visits and other trial procedures

You may not qualify if:

• Subjects presenting with any of the following will not be included in the trial:
• Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications (e.g. metal in the eye, claustrophobia);
• Unable to receive gas mixture by breathing because of contraindications;
• Participation in a clinical trial with a study drug that may impact lung function in the past 14 days; or
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
• Female; women at risk of pregnancy are required to have a confirmed negative blood pregnancy test at Screening if of childbearing potential prior to the MRI scan.

Sponsors & Collaborators

• Hal C Charles: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Study Officials

• Cecil Charles, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 24, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

US (1)