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Trial record 27 of 29 for:    Pulmonary Hypertension OR Vascular dementia OR Vascular Dementia OR Vascular Contributions to Cognitive Impairment and Dementia | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Non-Invasive Diagnosis of Pulmonary Vascular Disease Using Inhaled 129Xe Magnetic Resonance Imaging (XenonMRI)

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ClinicalTrials.gov Identifier: NCT03078192
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : June 21, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Bastiaan Driehuys, Duke University

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.

Condition or disease Intervention/treatment Phase
Pulmonary Vascular Disease Drug: GE-141, Hyperpolarized 129Xenon gas Device: MRI Phase 2

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:

1.1 Deploy and optimize 129Xe gas exchange MR spectroscopy and imaging, 129Xe ventilation MRI, structural 1H UTE MRI, and breath-hold 1H perfusion MRI.

1.2 Conduct comprehensive 1H-129Xe MRI in 10 patients with pure pulmonary arterial hypertension (PAH) 1.3 Conduct comprehensive MRI in 10 patients with pure left heart failure 1.4 Conduct comprehensive MRI in 10 patients with pure lung disease but no pulmonary hypertension 1.5 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:

2.1 Develop quantification/scoring methods based on PAH, left heart disease, and lung disease MRI 2.2 Develop reader training materials and train 3 expert readers 2.3 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:

3.1 Trained readers will evaluate 129Xe MRI, while blinded to the subject's disease state and will determine the presence and severity of PVD 3.2 Diagnostic accuracy of 129Xe MRI will be compared to the gold standard of hemodynamic and clinical criteria of PAH

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 = 0.72 vs. H1: AUC > 0.85, 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 = 0.72 represents a moderately accurate test while AUC = 0.85 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 127 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This will be a 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), 5 CTEPH in Aim 1; followed by a larger cohort of 92 subjects with PAH or other cardiac or pulmonary disease for MRI scans
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessor, the radiologist who is reading the imaging will be blinded to treatment.
Primary Purpose: Diagnostic
Official Title: Non-Invasive Diagnosis of Pulmonary Vascular Disease Using Inhaled 129Xe Magnetic Resonance Imaging
Actual Study Start Date : May 3, 2017
Estimated Primary Completion Date : November 14, 2020
Estimated Study Completion Date : November 14, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Xenon

Arm Intervention/treatment
Experimental: PVD, left heart disease, lung disease
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
Drug: 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
Other Name: Xe MRI

Device: MRI
Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon

Experimental: Pulmonary Vascular Disease
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
Drug: 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
Other Name: Xe MRI

Device: MRI
Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon




Primary Outcome Measures :
  1. Diagnostic Accuracy as Measured by ROC Analysis [ Time Frame: up to 2 weeks ]
    Determine diagnostic accuracy of XeMRI compared to the gold standard of hemodynamic and clinical criteria of pulmonary arterial hypertension



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Outpatients of either gender, age > 18
  2. Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed)
  3. Women of childbearing potential must have a negative urine pregnancy test. This will be confirmed before participation in this investigational protocol.
  4. Either has a diagnosis of PAH, isolated left heart disease or lung disease (chronic obstructive pulmonary disease or interstitial lung disease) or CTEPH using established clinical criteria.
  5. Patients undergoing right heart catheterization for evaluation of PAH or other cardiac or pulmonary disease for MRI scans

Exclusion criteria

  • 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
  • Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078192


Contacts
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Contact: Susana Almeida-Peters, RN 919-684-6237 susana.almeida-peters@duke.edu
Contact: Sudarshan Rajagopal, MD, PhD 919-684-2008 sudarshan.rajagopal@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Susana Almeida-Peters, RN, BS    919-684-6237    susana.almedia-peters@duke.edu   
Contact: Samantha Womack, MS    919-684-7931    Samantha.Womack@duke.edu   
Principal Investigator: Sudarshan Rajagopal, MD         
Sub-Investigator: Bastiann Driehays, PhD         
Sponsors and Collaborators
Bastiaan Driehuys
National Heart, Lung, and Blood Institute (NHLBI)

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Responsible Party: Bastiaan Driehuys, Professor, Duke University Medical Center, Duke University
ClinicalTrials.gov Identifier: NCT03078192     History of Changes
Other Study ID Numbers: Pro00079617
HHSN268201700001C ( Other Identifier: National Heart, Lung, and Blood Institutes )
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Bastiaan Driehuys, Duke University:
right heart catheterization for evaluation of PAH or other cardiac or pulmonary disease
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs