Trial Outcomes & Findings for Non-Invasive Diagnosis of Pulmonary Vascular Disease Using Inhaled 129Xe Magnetic Resonance Imaging (NCT NCT03078192)
NCT ID: NCT03078192
Last Updated: 2022-02-22
Results Overview
Determine diagnostic accuracy of XeMRI compared to the gold standard of hemodynamic and clinical criteria of pulmonary arterial hypertension (Hemodynamic criteria: mean pulmonary artery pressure \> 20 mmHg, pulmonary arterial wedge pressure ≤ 15 mmHg, and pulmonary vascular resistance ≥ 3 Wood units; Clinical criteria: absence of significant systolic dysfunction (LVEF \> 40%) or valvular heart disease (moderate or greater mitral or aortic valve disease); absence of significant obstructive or restrictive lung disease; absence of hypoxemic or hypercarbic respiratory failure; absence of chronic thromboembolic disease; absence of sickle cell anemia or other hemolytic anemias; absence of sarcoidosis). We used data from Arm 1 (the training set of patients with known pulmonary vascular disease (PVD), isolated left heart disease and lung disease) to determine thresholds for precapillary pulmonary hypertension used for diagnosis in Arm 2 (the test set of pulmonary vascular disease).
COMPLETED
PHASE2
62 participants
up to 2 weeks
2022-02-22
Participant Flow
Patients with PAH, CTEPH, left heart disease and lung disease will be recruited using inclusion/exclusion criteria. For the first phase of the study, whether patients are receiving approved therapies, enrolled in clinical trials, or receiving no therapy, all will be eligible for inclusion in this study. For the 2nd phase of the study, patients who have PAH and receiving approved therapies, patients who are being evaluated for PVD or other cardiac/pulmonary diseases will be included in the study.
Participant milestones
| Measure |
PVD, Left Heart Disease, Lung Disease
The study team recruited 30 subjects. Patients with Pulmonary Vascular Disease (10 subjects), isolated left-sided heart failure (10 subjects), and isolated lung disease(10 subjects) will undergo Xe MRI scans with GE-141, Hyperpolarized 129Xenon gas to develop diagnostic criteria for optimizing the sensitivity and specificity of XeMRI for the diagnosis of PVD
GE-141, Hyperpolarized 129Xenon gas: XeMRI scans will provide 3D images of ventilation and gas exchange. Subjects will inhale HP 129Xe from the dose delivery bags. Then the subject will be moved into the scanner and they will undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will under-go several MRI scans after inhalation of HPXe
MRI: Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon
|
Pulmonary Vascular Disease
the study team recuited 32 subjects being evaluated for undergoing right heart catheterization for evaluation of PAH or other cardiac or pulmonary disease for testing of diagnostic accuracy of XeMRI for diagnosis of PVD
GE-141, Hyperpolarized 129Xenon gas: XeMRI scans will provide 3D images of ventilation and gas exchange. Subjects will inhale HP 129Xe from the dose delivery bags. Then the subject will be moved into the scanner and they will undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will under-go several MRI scans after inhalation of HPXe
MRI: Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
32
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
PVD, Left Heart Disease, Lung Disease
The study team recruited 30 subjects. Patients with Pulmonary Vascular Disease (10 subjects), isolated left-sided heart failure (10 subjects), and isolated lung disease(10 subjects) will undergo Xe MRI scans with GE-141, Hyperpolarized 129Xenon gas to develop diagnostic criteria for optimizing the sensitivity and specificity of XeMRI for the diagnosis of PVD
GE-141, Hyperpolarized 129Xenon gas: XeMRI scans will provide 3D images of ventilation and gas exchange. Subjects will inhale HP 129Xe from the dose delivery bags. Then the subject will be moved into the scanner and they will undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will under-go several MRI scans after inhalation of HPXe
MRI: Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon
|
Pulmonary Vascular Disease
the study team recuited 32 subjects being evaluated for undergoing right heart catheterization for evaluation of PAH or other cardiac or pulmonary disease for testing of diagnostic accuracy of XeMRI for diagnosis of PVD
GE-141, Hyperpolarized 129Xenon gas: XeMRI scans will provide 3D images of ventilation and gas exchange. Subjects will inhale HP 129Xe from the dose delivery bags. Then the subject will be moved into the scanner and they will undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will under-go several MRI scans after inhalation of HPXe
MRI: Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
screen failure
|
0
|
3
|
Baseline Characteristics
Non-Invasive Diagnosis of Pulmonary Vascular Disease Using Inhaled 129Xe Magnetic Resonance Imaging
Baseline characteristics by cohort
| Measure |
PVD, Left Heart Disease, Lung Disease
n=30 Participants
Patients with Pulmonary Vascular Disease (10 subjects), isolated left-sided heart failure (10 subjects), and isolated lung disease(10 subjects) will undergo Xe MRI scans with GE-141, Hyperpolarized 129Xenon gas to develop diagnostic criteria for optimizing the sensitivity and specificity of XeMRI for the diagnosis of PVD
GE-141, Hyperpolarized 129Xenon gas: XeMRI scans will provide 3D images of ventilation and gas exchange. Subjects will inhale HP 129Xe from the dose delivery bags. Then the subject will be moved into the scanner and they will undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will under-go several MRI scans after inhalation of HPXe
MRI: Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon
|
Pulmonary Vascular Disease
n=32 Participants
92 subjects being evaluated for undergoing right heart catheterization for evaluation of PAH or other cardiac or pulmonary disease for testing of diagnostic accuracy of XeMRI for diagnosis of PVD
GE-141, Hyperpolarized 129Xenon gas: XeMRI scans will provide 3D images of ventilation and gas exchange. Subjects will inhale HP 129Xe from the dose delivery bags. Then the subject will be moved into the scanner and they will undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will under-go several MRI scans after inhalation of HPXe
MRI: Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 2 weeksDetermine diagnostic accuracy of XeMRI compared to the gold standard of hemodynamic and clinical criteria of pulmonary arterial hypertension (Hemodynamic criteria: mean pulmonary artery pressure \> 20 mmHg, pulmonary arterial wedge pressure ≤ 15 mmHg, and pulmonary vascular resistance ≥ 3 Wood units; Clinical criteria: absence of significant systolic dysfunction (LVEF \> 40%) or valvular heart disease (moderate or greater mitral or aortic valve disease); absence of significant obstructive or restrictive lung disease; absence of hypoxemic or hypercarbic respiratory failure; absence of chronic thromboembolic disease; absence of sickle cell anemia or other hemolytic anemias; absence of sarcoidosis). We used data from Arm 1 (the training set of patients with known pulmonary vascular disease (PVD), isolated left heart disease and lung disease) to determine thresholds for precapillary pulmonary hypertension used for diagnosis in Arm 2 (the test set of pulmonary vascular disease).
Outcome measures
| Measure |
Training Set - PVD, Isolated Left Heart Disease, Lung Disease
n=30 Participants
The study recruited 30 subjects being evaluated for undergoing right heart catheterization for evaluation of PAH or other cardiac or pulmonary disease for testing of diagnostic accuracy of XeMRI for diagnosis of PVD
GE-141, Hyperpolarized 129Xenon gas: XeMRI scans will provide 3D images of ventilation and gas exchange. Subjects will inhale HP 129Xe from the dose delivery bags. Then the subject will be moved into the scanner and they will undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will under-go several MRI scans after inhalation of HPXe
MRI: Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon
|
Test Set - Pulmonary Vascular Disease
n=32 Participants
The study recruited 32 subjects being evaluated for undergoing right heart catheterization for evaluation of PAH or other cardiac or pulmonary disease for testing of diagnostic accuracy of XeMRI for diagnosis of PVD
GE-141, Hyperpolarized 129Xenon gas: XeMRI scans will provide 3D images of ventilation and gas exchange. Subjects will inhale HP 129Xe from the dose delivery bags. Then the subject will be moved into the scanner and they will undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will under-go several MRI scans after inhalation of HPXe
MRI: Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon
|
|---|---|---|
|
Participants Determined to be True Positives for Pulmonary Arterial Hypertension
By Right Heart Cath · Pre-capillary pulmonary hypertension
|
10 Participants
|
15 Participants
|
|
Participants Determined to be True Positives for Pulmonary Arterial Hypertension
By Right Heart Cath · Isolated post-capillary pulmonary hypertension
|
10 Participants
|
5 Participants
|
|
Participants Determined to be True Positives for Pulmonary Arterial Hypertension
By Right Heart Cath · Combined pre- and post-capillary pulmonary hypertension
|
0 Participants
|
3 Participants
|
|
Participants Determined to be True Positives for Pulmonary Arterial Hypertension
By Right Heart Cath · Pulmonary hypertension (not pre or post)
|
0 Participants
|
2 Participants
|
|
Participants Determined to be True Positives for Pulmonary Arterial Hypertension
By Right Heart Cath · No pulmonary hypertension
|
10 Participants
|
7 Participants
|
|
Participants Determined to be True Positives for Pulmonary Arterial Hypertension
By Xenon MRI scan · Pre-capillary pulmonary hypertension
|
10 Participants
|
18 Participants
|
|
Participants Determined to be True Positives for Pulmonary Arterial Hypertension
By Xenon MRI scan · Isolated post-capillary pulmonary hypertension
|
10 Participants
|
8 Participants
|
|
Participants Determined to be True Positives for Pulmonary Arterial Hypertension
By Xenon MRI scan · Combined pre- and post-capillary pulmonary hypertension
|
0 Participants
|
0 Participants
|
|
Participants Determined to be True Positives for Pulmonary Arterial Hypertension
By Xenon MRI scan · Pulmonary hypertension (not pre or post)
|
0 Participants
|
0 Participants
|
|
Participants Determined to be True Positives for Pulmonary Arterial Hypertension
By Xenon MRI scan · No pulmonary hypertension
|
10 Participants
|
6 Participants
|
Adverse Events
PVD, Left Heart Disease, Lung Disease
Pulmonary Vascular Disease
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place