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New treatment option for Interstitial Lung Disease
Official title 129Xe MRI Cardiopulmonary
ClinicalTrials.gov ID: NCT06038630
What this study is testing
What is Hyperpolarized Xe129?
Hyperpolarized Xe129 is an investigational medicine, being studied as a potential treatment for interstitial lung disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- for Healthy Volunteers: ( people must meet all of the following to be eligible for enrollment into the trial)
- 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
You likely can't join if
- for All people: people 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
See the full eligibility criteria
- for Healthy Volunteers: ( people must meet all of the following to be eligible for enrollment into the trial)
- 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 for Transfusion and Phlebotomy Patients:
- 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
- Healthy volunteers undergoing voluntary whole blood donation (healthy volunteer noted above) for Oxygen Administration Patients:
- 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
- Physician diagnosis of Interstitial Lung Disease by a pulmonologist using established criteria or physician referral of patient with dyspnea OR
- Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
- Patients with a diagnosis of CTEPH, defined as mean PA pressure \>20 mmHg with a pulmonary vascular resistance \>2 WU and pulmonary capillary wedge pressure ≤15 mmHg at right heart catheterization with evidence of...
- Scheduled for pulmonary thromboendoarterectomy (PTE) surgery and willing to re-turn 3-6 months after for optional follow-up scans OR
- Healthy Volunteer (criteria noted above) for Acute or Chronic Pulmonary Embolism Patients:
- 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 (Acute or Chronic)
- Acute Pulmonary Embolism
- Patients presenting with acute PE 24-48hrs post-admission
- Willing to return after 3-6 months of anti-coagulation therapy OR
- Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
- Patients with a diagnosis of CTEPH, defined as mean PA pressure \>20 mmHg with a pulmonary vascular resistance \>2 WU and pulmonary capillary wedge pressure ≤15 mmHg at right heart catheterization with evidence of...
- Scheduled for pulmonary thromboendoarterectomy (PTE) surgery and willing to re-turn 3-6 months after for optional follow-up scans
- for All people: people 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
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.