129Xe MRI Cardiopulmonary

NCT06038630 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: Pro00113114
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this NIH-sponsored study is to characterize three biomarkers derived from 129Xe gas exchange MRI and to understand how they change in response to interventions.

Conditions

Chronic Thromboembolic Pulmonary Hypertension; Interstitial Lung Disease; Acute Pulmonary Embolism; Anemia; Polycythemia; Dyspnea

Outcome Measures

Primary Outcomes (3)

• Change in RBC to Membrane Ratio Pre and Post Transfusion or Apheresis

  The investigators will validate the Hb (hemoglobin) correction model in anemia patients pre/post transfusion and blood donors pre/post apheresis.

  Up to 5 days pre/post transfusion or apheresis

• Change in RBC (red blood cell) Chemical Shift After Oxygen Administration

  To test the effects of oxygen on 129Xe MRI/MRS in healthy subjects, those with ILD, those with dyspnea, and patients with chronic thromboembolic pulmonary hypertension (CTEPH).

  Baseline, 1 day

• Change in RBC Oscillation Amplitude Post Therapy

  Patients with chronic PE are treated surgically and those with acute PE are treated with anticoagulation therapy.

  Baseline, 3-6 months post-treatment

Study Arms (3)

Transfusion and Phlebotomy Patients

ACTIVE COMPARATOR

Individuals receiving treatment for their blood hemoglobin levels or are a healthy volunteer who is planning to donate blood.

Drug: Hyperpolarized Xe129

Oxygen Administration Patients

ACTIVE COMPARATOR

Individuals diagnosed with a chronic blood clot in their lungs and are planning on having surgery to remove it (CTEPH), or have an interstitial lung disease (ILD), or have dyspnea, or are a healthy volunteer.

Drug: Hyperpolarized Xe129; Other: Oxygen Administration

Acute or Chronic Pulmonary Embolism Patients

ACTIVE COMPARATOR

Individuals recently diagnosed with a blood clot in their lungs.

Drug: Hyperpolarized Xe129

Interventions

Hyperpolarized Xe129 DRUG

Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject TLC followed by a breath hold of up to 15 seconds.

Acute or Chronic Pulmonary Embolism Patients; Oxygen Administration Patients; Transfusion and Phlebotomy Patients

Oxygen Administration OTHER

Oxygen administration

Oxygen Administration Patients

Eligibility Criteria

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

You may qualify if:

• Outpatients of either gender, age \> 18
• Willing and able to give informed consent and adhere to visit/protocol (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/week for \> 1 year
• In-patient or outpatients of either sex, age \> 18
• Willing and able to give informed consent and adhere to visit/protocol
• And one of the following:
• Patients who are scheduled to receive a red cell transfusion for anemia.
• Patients who are scheduled to undergo therapeutic phlebotomy to treat erythrocytosis or polycythemia
• In-patient or outpatients of either sex, age \> 18
• Willing and able to give informed consent and adhere to visit/protocol
• And one of the following categories (ILD, Dyspnea, CTEPH, or Healthy):
• Interstitial Lung Disease or Dyspnea

You may not qualify if:

• Subjects presenting with any of the following will not be included in the trial:
• MRI is contraindicated based on responses to MRI screening questionnaire
• Subject is pregnant or lactating
• Resting O2 saturation \<90% with maximum supplemental O2 delivered by nasal canula
• 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 129Xe vest coil used for MRI
• Subject cannot hold his/her breath for 10 seconds
• Subject deemed unlikely to be able to comply with instructions during imaging
• Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

Sponsors & Collaborators

• Bastiaan Driehuys: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial; Anemia; Polycythemia; Dyspnea

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Joseph Mammarappallil, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bastiaan Driehuys, PhD

CONTACT

919-684-7786; bastiaan.driehuys@duke.edu

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: September 8, 2023
• First Posted: September 15, 2023
• Study Start: January 12, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• 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: 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 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 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 (1)