19F MRI to Evaluate Regional Ventilation in Healthy Subjects and Subjects With Cystic Fibrosis

NCT03489590 | Completed Early Phase 1

• 1 other identifier: 14-0509
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

An open label non-randomized study enrolling up to 20 healthy participants and up to 30 participants with cystic fibrosis to establish a healthy versus disease comparison. Each participant will receive a mixture of inert gas (perfluoropropane (PFP)) in a ratio of 79% PFP to 21% oxygen as a contrast agent to enhance visualization of the airway and alveolar spaces using magnetic resonance imaging of inert gas/oxygen mixtures. The study consists of a screening visit followed by up to 2 study visits.

Conditions

Cystic Fibrosis

Keywords

Lung; Imaging; Hyperpolarized; Perfluorinated; MRI

Outcome Measures

Primary Outcomes (1)

• Obtain technically sufficient 19F MRI images

  Determine if 19F gas images of the human lung and airways can be obtained in both single breath-hold and gated breathing imaging studies with adequate signal level and image contrast to extract regional lung ventilation information.

  1 day

Secondary Outcomes (2)

• Determine the reproducibility of ventilation assessments in the adult cystic fibrosis (CF) population.

  1 week

• Compare quantitative and qualitative image measures of lung ventilation using 19F MRI imaging to spirometric values.

  1 day

Study Arms (1)

19F MRI with PFP

EXPERIMENTAL

PFP gas will be administered using a full-face mask during the MRI. Images are acquired during 12-second breath-hold after every 3rd breath. Before and after the MRI is complete, participants will perform spirometry maneuvers in a room outside of the magnet.

Drug: PFP

Interventions

PFP DRUG

* Composition: 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 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.

Also known as: Perfluoropropane gas (C3F8); 19F

19F MRI with PFP

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-smokers (\<10 pack-year history, and no active smoking in last 1 year);
• No evidence of prior lung disease or lung injury by medical history, physical exam, and/or spirometry testing;
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
• Participants must be willing and able to comply with scheduled visits and other trial procedures.

You may not qualify if:

• Active or past smokers with less than 1 years since quitting or \>10 pack-year smoking history
• Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications including
• Occupation (past or present) of machiner, welder, grinder;
• Injury to the eye involving a metallic object
• Injury to the body by a metallic object (bullet, BB, shrapnel)
• Presence of a cardiac pacemaker or defibrillator
• Presence of aneurysm clips
• Presence of carotid artery vascular clamp
• Presence of neurostimulator
• Presence of insulin or infusion pump
• Presence of implanted drug infusion device that is not known to be MRI compatible (i.e., was placed outside of UNCH or is older than 10 years)
• Bone growth or fusion simulator
• Presence of cochlear, otologic or ear implant
• Any type of prosthesis (eye, penile, etc.)
• Artificial limb or joint

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (3)

• Couch MJ, Ball IK, Li T, Fox MS, Littlefield SL, Biman B, Albert MS. Pulmonary ultrashort echo time 19F MR imaging with inhaled fluorinated gas mixtures in healthy volunteers: feasibility. Radiology. 2013 Dec;269(3):903-9. doi: 10.1148/radiol.13130609. Epub 2013 Oct 28.

  PMID: 23985278 BACKGROUND

• Halaweish AF, Moon RE, Foster WM, Soher BJ, McAdams HP, MacFall JR, Ainslie MD, MacIntyre NR, Charles HC. Perfluoropropane gas as a magnetic resonance lung imaging contrast agent in humans. Chest. 2013 Oct;144(4):1300-1310. doi: 10.1378/chest.12-2597.

  PMID: 23722696 BACKGROUND

• Goralski JL, Chung SH, Glass TM, Ceppe AS, Akinnagbe-Zusterzeel EO, Trimble AT, Boucher RC, Soher BJ, Charles HC, Donaldson SH, Lee YZ. Dynamic perfluorinated gas MRI reveals abnormal ventilation despite normal FEV1 in cystic fibrosis. JCI Insight. 2020 Jan 30;5(2):e133400. doi: 10.1172/jci.insight.133400.

  PMID: 31855577 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Jennifer L Goralski, MD

  University of North Carolina, Chapel Hill

  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

Model Details: This study enrolls both healthy volunteers and volunteers with cystic fibrosis. Both healthy and CF participants will receive the same treatment throughout the entirety of the study.

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 5, 2018
• Study Start: July 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)