RECRUITING

129Xe MRI Cardiopulmonary

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

129Xe Gas Exchange MRI to Visualize Cardiopulmonary Function

Quick Facts

Study Start:2024-01-12

Study Completion:2028-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06038630

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Outpatients of either gender, age \> 18 2. Willing and able to give informed consent and adhere to visit/protocol (Consent must be given before any study procedures are performed.) 3. Subject has no diagnosed pulmonary conditions 4. Subject has not smoked in the previous 5 years 5. Smoking history, if any, is less than or equal to 5 pack-years 6. No history of using other inhaled products more than 1/week for \> 1 year 1. In-patient or outpatients of either sex, age \> 18 2. Willing and able to give informed consent and adhere to visit/protocol 1. Patients who are scheduled to receive a red cell transfusion for anemia. 2. Patients who are scheduled to undergo therapeutic phlebotomy to treat erythrocytosis or polycythemia 3. Healthy volunteers undergoing voluntary whole blood donation (healthy volunteer inclusion criteria noted above) 1. In-patient or outpatients of either sex, age \> 18 2. Willing and able to give informed consent and adhere to visit/protocol 1. Interstitial Lung Disease or Dyspnea * Physician diagnosis of Interstitial Lung Disease by a pulmonologist using established criteria or physician referral of patient with dyspnea 2. 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 chronic thromboembolic disease on clinical imaging after 3 months of anticoagulation * Scheduled for pulmonary thromboendoarterectomy (PTE) surgery and willing to re-turn 3-6 months after for optional follow-up scans 3. Healthy Volunteer (criteria noted above) 1. In-patient or outpatients of either sex, age \> 18 2. Willing and able to give informed consent and adhere to visit/protocol 1. Acute Pulmonary Embolism * Patients presenting with acute PE 24-48hrs post-admission * Willing to return after 3-6 months of anti-coagulation therapy 2. 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 chronic thromboembolic disease on clinical imaging after 3 months of anticoagulation * Scheduled for pulmonary thromboendoarterectomy (PTE) surgery and willing to re-turn 3-6 months after for optional follow-up scans 1. MRI is contraindicated based on responses to MRI screening questionnaire 2. Subject is pregnant or lactating 3. Resting O2 saturation \<90% with maximum supplemental O2 delivered by nasal canula 4. Respiratory illness of a bacterial or viral etiology within 30 days of MRI 5. Subject has history of any known ventricular cardiac arrhythmia 6. Subject has history of cardiac arrest within the last year 7. Subject does not fit into 129Xe vest coil used for MRI 8. Subject cannot hold his/her breath for 10 seconds 9. Subject deemed unlikely to be able to comply with instructions during imaging 10. 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

1. Outpatients of either gender, age \> 18
2. Willing and able to give informed consent and adhere to visit/protocol (Consent must be given before any study procedures are performed.)
3. Subject has no diagnosed pulmonary conditions
4. Subject has not smoked in the previous 5 years
5. Smoking history, if any, is less than or equal to 5 pack-years
6. No history of using other inhaled products more than 1/week for \> 1 year
1. In-patient or outpatients of either sex, age \> 18
2. Willing and able to give informed consent and adhere to visit/protocol
1. Patients who are scheduled to receive a red cell transfusion for anemia.
2. Patients who are scheduled to undergo therapeutic phlebotomy to treat erythrocytosis or polycythemia
3. Healthy volunteers undergoing voluntary whole blood donation (healthy volunteer inclusion criteria noted above)
1. In-patient or outpatients of either sex, age \> 18
2. Willing and able to give informed consent and adhere to visit/protocol
1. Interstitial Lung Disease or Dyspnea
* Physician diagnosis of Interstitial Lung Disease by a pulmonologist using established criteria or physician referral of patient with dyspnea
2. 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 chronic thromboembolic disease on clinical imaging after 3 months of anticoagulation
* Scheduled for pulmonary thromboendoarterectomy (PTE) surgery and willing to re-turn 3-6 months after for optional follow-up scans
3. Healthy Volunteer (criteria noted above)
1. In-patient or outpatients of either sex, age \> 18
2. Willing and able to give informed consent and adhere to visit/protocol
1. Acute Pulmonary Embolism
* Patients presenting with acute PE 24-48hrs post-admission
* Willing to return after 3-6 months of anti-coagulation therapy
2. 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 chronic thromboembolic disease on clinical imaging after 3 months of anticoagulation
* Scheduled for pulmonary thromboendoarterectomy (PTE) surgery and willing to re-turn 3-6 months after for optional follow-up scans
1. MRI is contraindicated based on responses to MRI screening questionnaire
2. Subject is pregnant or lactating
3. Resting O2 saturation \<90% with maximum supplemental O2 delivered by nasal canula
4. Respiratory illness of a bacterial or viral etiology within 30 days of MRI
5. Subject has history of any known ventricular cardiac arrhythmia
6. Subject has history of cardiac arrest within the last year
7. Subject does not fit into 129Xe vest coil used for MRI
8. Subject cannot hold his/her breath for 10 seconds
9. Subject deemed unlikely to be able to comply with instructions during imaging
10. 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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Bastiaan Driehuys, PhD

CONTACT

919-684-7786

bastiaan.driehuys@duke.edu

Principal Investigator

Joseph Mammarappallil, MD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke University Medical Center

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Bastiaan Driehuys

Joseph Mammarappallil, MD, PRINCIPAL_INVESTIGATOR, Duke University

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 Registration Dates

Study Start Date2024-01-12

Study Completion Date2028-06-30

Study Record Updates

Study Start Date2024-01-12

Study Completion Date2028-06-30

Terms related to this study

Additional Relevant MeSH Terms

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