Phase Resolved Functional Lung MRI and Oscillometry for the Observation of Healthy Lung Function (PROOF)

This study will examine the relationship of airways resistance measured by oscillometry with ventilation defects measured by Phase Resolved Functional Lung (PREFUL) MRI in healthy human subjects.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy; Breathing; Lung Function Decreased; MRI Imaging
• Intervention / Treatment: Device: Airway Oscillometer; Diagnostic test: Phase Resolved Functional Lung MRI

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Patrick Donohue, MD; Phone Number: 585-210-9301; Email: patrick_donohue@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
      • Contact: Partick Donohue, MD; Phone Number: 585-210-9301; Email: patrick_donohue@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Up to twenty (20) healthy human subjects will be recruited from the outpatient clinics at the University of Rochester Medical Center and the Mary Parkes Asthma Center.

Description

Inclusion Criteria:

• Age 18 years or older
• Ability to provide consent
• Willingness to perform MRI and breathing test
• Must be able to speak and understand English

Exclusion Criteria:

• Pregnant
• Unable or willing to provide consent or perform the required maneuvers for testing.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All participants	Device: Airway Oscillometer; The termoflo c-100 Airwave Oscillometer System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).; Diagnostic test: Phase Resolved Functional Lung MRI; The Phase Resolved Functional Lung (PREFUL) MRI technique acquires images of the lung so that measures of ventilatory defect percentage can be calculated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oscillometer	The oscillometer will collect an airway impedance measurement which is made up of multiple variables.	Single measurement, approximately 1 day
Phase Resolved Functional Lung (PREFUL) MRI	PREFUL MRI will acquire images of the lungs and a measurement called the ventilatory defect percentage (or VDP) will be calculated.	Single measurement, approximately 1 day

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiratory Aspiration
• Other Study ID Numbers: STUDY00011843

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No