Hyperpolarized Xenon MRI in Adults With Pulmonary Hypertension in Interstitial Lung Disease and Systemic Sclerosis

NCT07821398 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: Pro00120593R01HL126771
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate a noninvasive magnetic resonance imaging technique using hyperpolarized xenon gas to measure lung function in adults with interstitial lung disease, pulmonary hypertension, and systemic sclerosis. Researchers will assess whether MRI measurements correlate with clinical measures of lung and vascular function.

Conditions

Interstitial Lung Disease; Pulmonary Hypertension; Systemic Sclerosis

Keywords

Interstitial Lung Disease; Pulmonary Hypertension; Magnetic Resonance Imaging; Systemic Sclerosis

Outcome Measures

Primary Outcomes (2)

• Diagnostic Accuracy for Detection of Pulmonary Hypertension (sensitivity)

  Sensitivity of pre-specified 129Xe MRI biomarkers for identifying pre-capillary pulmonary hypertension in participants with systemic sclerosis, using right-heart catheterization as the reference standard.

  Single study visit, Day 1

• Diagnostic Accuracy for Detection of Pulmonary Hypertension (specificity)

  Specificity of pre-specified 129Xe MRI biomarkers for identifying pre-capillary pulmonary hypertension in participants with systemic sclerosis, using right-heart catheterization as the reference standard.

  Single study visit, Day 1

Secondary Outcomes (2)

• RBC Oscillation Imaging Amplitude Defect Percentage

  Single study visit, Day 1

• Whole-Lung RBC Chemical Shift

  Single study visit, Day 1

Study Arms (1)

Hyperpolarized Xenon MRI

EXPERIMENTAL

Participants undergo hyperpolarized Xenon MRI imaging and clinical assessments.

Drug: Hyperpolarized 129 Xenon Gas

Interventions

Hyperpolarized 129 Xenon Gas DRUG

Hyperpolarized xenon gas is inhaled during MRI to evaluate lung ventilation and gas exchange.

Hyperpolarized Xenon MRI

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years at enrollment.
• Participant is willing and able to provide written informed consent.
• Able (in the Investigator's opinion) and willing to comply with all study requirements.
• Participant has or is suspected to have one of the following pulmonary conditions:
• Healthy volunteers: aged 18-30 years; no known cardiopulmonary disease; has not smoked tobacco products 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 OR
• ILD-PH: ≥18 years; ILD diagnosis; precapillary PH by RHC (mPAP \>20 mmHg, PVR \>2 WU, PCWP ≤15 mmHg) within the specified window OR
• SSc: systemic sclerosis diagnosis with or without PH

You may not qualify if:

• Any condition which, in the opinion of the Investigator, would make it unsafe or unsuitable for the participants to undergo MRI (for example: presence of an implanted or external MRI unsafe device that cannot be removed, body weight exceeding table limitations, inability to lie flat, or severe claustrophobia).
• Inability to hold breath for 10-15 seconds for required imaging or for completion of DLCO measurements.
• Active pulmonary infection or lung cancer.
• Recent respiratory infection or pulmonary disease exacerbation within 4 weeks of screening.
• Participants who are known to be pregnant or lactating.
• Concurrent enrollment and participation in a study which, in the opinion of the Investigator, would interfere with the study compliance, or outcome assessments or would prohibit the collection of the required data points.

Sponsors & Collaborators

• Bastiaan Driehuys: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

MeSH Terms

Conditions

Lung Diseases, Interstitial; Hypertension, Pulmonary; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Joseph Mammarappallil

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 15, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): April 20, 2030
• Study Completion (Estimated): April 20, 2030
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share