Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease

NCT04855305 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: Pro00107570R01HL126771
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this multi-centered, NIH-sponsored study is to to develop an optimal protocol for using noninvasive 129Xe gas exchange MRI to detect changing disease activity in interstitial lung diseases (ILDs).

Conditions

Interstitial Lung Diseases

Outcome Measures

Primary Outcomes (5)

• Thoracic cavity volume measured in liters.

  4 years

• RBC/barrier signal ratio (unitless).

  4 years

• Coefficient of repeatability of RBC/barrier signal ratio (unitless).

  4 years

• Echo time to separate RBC and barrier signals by 90 degrees (ms).

  4 years

• Population-wide RBC/barrier signal ratio (unitless).

  4 years

Study Arms (2)

Patients with Interstitial Lung Disease

ACTIVE COMPARATOR

Drug: Hyperpolarized 129Xe

Healthy Volunteers

ACTIVE COMPARATOR

Drug: Hyperpolarized 129Xe

Interventions

Hyperpolarized 129Xe DRUG

Hyperpolarized 129Xe will be administered in multiple doses in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.

Healthy Volunteers; Patients with Interstitial Lung Disease

Eligibility Criteria

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

You may not qualify if:

• Outpatients of either gender, age greater than or equal to 18 years
• Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)
• Subject has no diagnosed pulmonary conditions
• Subject has not smoked in the previous 5 years
• Smoking history, if any, is less than or equal to 5 pack-years
• No history of using other inhaled products more than 1 time per week for \> 1 year
• Subject is less than 18 years old
• MRI is contraindicated based on responses to MRI screening questionnaire
• Subject is pregnant or lactating
• Resting oxygen saturation on room air \<90%
• Respiratory illness of a bacterial or viral etiology within 30 days of MRI
• Subject has history of any known ventricular cardiac arrhythmia
• Subject has history of cardiac arrest within the last year
• Subject does not fit into Xe vest coil used for MRI 129
• Subject cannot hold his/her breath for 15 seconds

Sponsors & Collaborators

• Bastiaan Driehuys: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• University of Cincinnati: collaborator
• University of Iowa: collaborator

Study Sites (4)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Joseph Mammarappallil, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 22, 2021
• Study Start: November 12, 2021
• Primary Completion: June 11, 2025
• Study Completion: June 11, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: A major focus of this work is sharing and dissemination of the image acquisition and analysis methods we develop as well as standard operating procedures for 129Xe MRI. In all instances we will adhere to the NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources for Recipients of NIH Grants and Contracts on Obtaining (https://grants.nih.gov/policy/sharing.htm) and Disseminating Biomedical Research Re-sources (issued December 1999). However, we intend to greatly exceed these requirements, making as much of our work freely available to the broader research community either before, or immediately after publication of manuscripts, as well as through PubMedCentral. While we we will provide relevant protocols upon request at any time, we further intend to pursue several proactive data sharing mechanisms.
• Access Criteria: We are committed to making de-identified datasets and image analysis available to to qualified investigators. When required scientifically, data including identifiers will be shared under an agreement that provides for: (1) a commitment to using data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data appropriately; and (3) a commitment to destroying or returning the data after analyses are completed.

Locations

US (4)