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

NCT03078192 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: Pro00079617HHSN268201700001C
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Vascular Disease

Keywords

right heart catheterization for evaluation of PAH or other cardiac or pulmonary disease

Outcome Measures

Primary Outcomes (1)

• Participants Determined to be True Positives for Pulmonary Arterial Hypertension

  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).

  up to 2 weeks

Study Arms (2)

Training Set - PVD, Isolated Left Heart Failure, Isolated Lung Disease

EXPERIMENTAL

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; Device: MRI

Test Set - Pulmonary Vascular Disease

EXPERIMENTAL

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; Device: MRI

Interventions

GE-141, Hyperpolarized 129Xenon gas DRUG

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

Also known as: Xe MRI

Test Set - Pulmonary Vascular Disease; Training Set - PVD, Isolated Left Heart Failure, Isolated Lung Disease

MRI DEVICE

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

Test Set - Pulmonary Vascular Disease; Training Set - PVD, Isolated Left Heart Failure, Isolated Lung Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients of either gender, age \> 18
• Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed)
• Women of childbearing potential must have a negative urine pregnancy test. This will be confirmed before participation in this investigational protocol.
• 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.
• Patients undergoing right heart catheterization for evaluation of PAH or other cardiac or pulmonary disease for MRI scans

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bastiaan Driehuys: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Results Point of Contact

• Title: Bastiaan Driehuys
• Organization: Duke University Medical Center

bastiaan.driehuys@duke.edu

919-684-7786

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor, the radiologist who is reading the imaging will be blinded to treatment.
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Duke University Medical Center

Model Details: 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

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 13, 2017
• Study Start: May 3, 2017
• Primary Completion: October 22, 2020
• Study Completion: October 22, 2020
• Last Updated: February 22, 2022
• Results First Posted: February 22, 2022

Record last verified: 2022-01

Locations

US (1)