Ignite Creation Date:
2024-05-06 @ 9:47 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03078192
Status:
COMPLETED
Last Update Posted:
2022-02-22
First Post:
2017-02-24
Brief Title:
Non-Invasive Diagnosis of Pulmonary Vascular Disease Using Inhaled 129Xe Magnetic Resonance Imaging
Sponsor:
Bastiaan Driehuys
Organization:
Duke University
Study Overview
Official Title:
Non-Invasive Diagnosis of Pulmonary Vascular Disease Using Inhaled 129Xe Magnetic Resonance Imaging
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
XenonMRI
Brief Summary:
This study seeks to deploy several forms of 129Xe MRI contrast as well as emerging conventional proton MRI technqiues for imaging lung structure and perfusion Specifically the 129Xe MRI scans will provide 3D images of ventilation and gas exchange and spectroscopic indices will be evaluated to test gas exchange dynamics with high temporal resolution The conventional 1H MRI scans will include a free-breathing ultra-short echo time UTE scan that provides images similar to that of a CT scan In addition to characterize perfusion and vascular dimensions directly patients will undergo a gadolinium-enhanced perfusion scan
Detailed Description:
This study seeks to deploy several forms of 129Xe MRI contrast as well as emerging conventional proton MRI technqiues for imaging lung structure and perfusion Specifically the 129Xe MRI scans will provide 3D images of ventilation and gas exchange and spectroscopic indices will be evaluated to test gas exchange dynamics with high temporal resolution The conventional 1H MRI scans will include a free-breathing ultra-short echo time UTE scan that provides images similar to that of a CT scan In addition to characterize perfusion and vascular dimensions directly patients will undergo a gadolinium-enhanced perfusion scan The overall aims of the study are as follows
Aim 1 Perform 129Xe MRI scans in cohorts of patients with PVD isolated left sided heart failure and isolated lung disease
11 Deploy and optimize 129Xe gas exchange MR spectroscopy and imaging 129Xe ventilation MRI structural 1H UTE MRI and breath-hold 1H perfusion MRI
12 Conduct comprehensive 1H-129Xe MRI in 10 patients with pure pulmonary arterial hypertension PAH 13 Conduct comprehensive MRI in 10 patients with pure left heart failure 14 Conduct comprehensive MRI in 10 patients with pure lung disease but no pulmonary hypertension 15 Conduct comprehensive MRI in 5 patients with Chronic thromboembolic pulmonary hypertension CTEPH pre and post PTE surgery
Aim 2 Develop diagnostic criteria for optimizing the sensitivity and specificity of 129Xe MRI for the diagnosis of PVD
21 Develop quantificationscoring methods based on PAH left heart disease and lung disease MRI 22 Develop reader training materials and train 3 expert readers 23 Begin prospective recruitment of 92 patients being evaluated for PAH for MRI scans These patients may be asked to return for a second scan in the study at a time no earlier than 48hr after their last xenon dose
Aim 3 Perform a larger single-blind study testing the diagnostic accuracy of 129Xe MRI for diagnosis of PVD
31 Trained readers will evaluate 129Xe MRI while blinded to the subjects disease state and will determine the presence and severity of PVD 32 Diagnostic accuracy of 129Xe MRI will be compared to the gold standard of hemodynamic and clinical criteria of PAH
1 For this PFTs are not necessary so they are ancillary
2 However they are a standard way to characterize patients for publications etc so we would like to get them if we can Getting them from the medical record is perfectly adequate for this pur-pose
i If PFTs are not available from the medical record they are not so critical as to pre-vent us from enrolling the subject In publications we will simply acknowledge the realities of COVID for this missing data
This will be an single-blinded open-label study enrolling volunteers and patients with pure PAH 10 subjects pure left heart disease 10 subjects and pure lung disease 10 subjects Aim 1 followed by a larger cohort of 92 subjects being evaluated for PAH Aim 2 The investigators plan to consent to 127 subjects
The sample size calculation is based on testing whether the proposed diagnostic test based on Xe MRI has accuracy comparable to imaging diagnostic procedures in clinical practice such as mammography To this end the investigator proposes to test the hypotheses H0 AUC 072 vs H1 AUC 085 where area under the curve AUC is a summary measure of diagnostic accuracy obtained as the the area under the receiver operating characteristic ROC curve which displays the tradeoff between sensitivity and specificity for our proposed Xe MRI based diagnostic test Here AUC 072 represents a moderately accurate test while AUC 085 represents accuracy comparable to clinical mammography Based on a one sided one sample test with variances approximated using the binormal model the investigator estimates a minimum sample size of 46 normals and 46 with disease will be required to test the above hypotheses at a significance level of 5 with 80 power
Aim 1 Perform 129Xe MRI scans in cohorts of patients with PVD isolated left sided heart failure and isolated lung disease
11 Deploy and optimize 129Xe gas exchange MR spectroscopy and imaging 129Xe ventilation MRI structural 1H UTE MRI and breath-hold 1H perfusion MRI
12 Conduct comprehensive 1H-129Xe MRI in 10 patients with pure pulmonary arterial hypertension PAH 13 Conduct comprehensive MRI in 10 patients with pure left heart failure 14 Conduct comprehensive MRI in 10 patients with pure lung disease but no pulmonary hypertension 15 Conduct comprehensive MRI in 5 patients with Chronic thromboembolic pulmonary hypertension CTEPH pre and post PTE surgery
Aim 2 Develop diagnostic criteria for optimizing the sensitivity and specificity of 129Xe MRI for the diagnosis of PVD
21 Develop quantificationscoring methods based on PAH left heart disease and lung disease MRI 22 Develop reader training materials and train 3 expert readers 23 Begin prospective recruitment of 92 patients being evaluated for PAH for MRI scans These patients may be asked to return for a second scan in the study at a time no earlier than 48hr after their last xenon dose
Aim 3 Perform a larger single-blind study testing the diagnostic accuracy of 129Xe MRI for diagnosis of PVD
31 Trained readers will evaluate 129Xe MRI while blinded to the subjects disease state and will determine the presence and severity of PVD 32 Diagnostic accuracy of 129Xe MRI will be compared to the gold standard of hemodynamic and clinical criteria of PAH
1 For this PFTs are not necessary so they are ancillary
2 However they are a standard way to characterize patients for publications etc so we would like to get them if we can Getting them from the medical record is perfectly adequate for this pur-pose
i If PFTs are not available from the medical record they are not so critical as to pre-vent us from enrolling the subject In publications we will simply acknowledge the realities of COVID for this missing data
This will be an single-blinded open-label study enrolling volunteers and patients with pure PAH 10 subjects pure left heart disease 10 subjects and pure lung disease 10 subjects Aim 1 followed by a larger cohort of 92 subjects being evaluated for PAH Aim 2 The investigators plan to consent to 127 subjects
The sample size calculation is based on testing whether the proposed diagnostic test based on Xe MRI has accuracy comparable to imaging diagnostic procedures in clinical practice such as mammography To this end the investigator proposes to test the hypotheses H0 AUC 072 vs H1 AUC 085 where area under the curve AUC is a summary measure of diagnostic accuracy obtained as the the area under the receiver operating characteristic ROC curve which displays the tradeoff between sensitivity and specificity for our proposed Xe MRI based diagnostic test Here AUC 072 represents a moderately accurate test while AUC 085 represents accuracy comparable to clinical mammography Based on a one sided one sample test with variances approximated using the binormal model the investigator estimates a minimum sample size of 46 normals and 46 with disease will be required to test the above hypotheses at a significance level of 5 with 80 power
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HHSN268201700001C | OTHER | National Heart Lung and Blood Institutes | None |