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

September 8, 2026 updated by: Patrick Donohue, University of Rochester
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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: Single measurement, approximately 1 day
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
Time Frame: Single measurement, approximately 1 day
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

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 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)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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