129 Xenon MRI as a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 129Xe Hyperpolarized.
- Who it may be relevant to
- Registry conditions: Pulmonary Arterial Hypertension, Idiopathic Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension Associated With Connective Tissue Disease (Disorder), Connective Tissue Diseases. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The overall study objectives outlined in this study are to derive 129Xe MRI pulmonary vascular biomarker signatures that differentiate common subtypes of PAH and to determine the ability of 129Xe MRI to longitudinally monitor disease progression and response to therapy in PAH, with the aid of additional assessments, such as labs, echocardiography, and six-minute walk distance (6MWD).
Detailed description
Subject Enrollment This study will consent and enroll 20 subjects total.
• For Arm 1, 10 subjects with Idiopathic Pulmonary Arterial Hypertension (IPAH) will be consented and enrolled. For Arm 2, 10 subjects with Connective Tissue Disease Associated Pulmonary Arterial Hypertension (PAH-CTD) will be consented and enrolled.
Study Design This study will be observational. Subjects in both arms of the trial will undergo a 129Xe MRI/MRS at timepoints of baseline, 3 months, 6 months, and 12 months. In addition to the this, data from standard of care assessments, such as labs, echocardiography, and six-minute walk distance (6MWD), will also collected at these timepoints.
Primary Study Endpoints The primary endpoint for this trial will be the change in defect + low percentage of RBC signal on hyperpolarized 129Xe MRI from baseline to 12 months
Secondary Study Endpoints
There will be several secondary endpoints for this trial:
* Change in regional and global RBC Oscillation Amplitudes on hyperpolarized 129Xe MR spectroscopy from baseline to 12 months * Change in 6MWD from baseline to 12 months * Change in NTproBNP from baseline to 12 months * Change in WHO FC from baseline to 12 months
Primary Safety Endpoints
There will be several primary safety endpoints for this trial:
* Frequency of Adverse Events (AE) and/or Serious Adverse Events (SAE) * Withdrawals due to adverse event or death * Incidence of Adverse Events of Significant Interest (AESI): * Electrocardiogram and any findings * Physical examination and vital signs
Interventions
- Drug 129Xe Hyperpolarized
Each xenon dose will be limited to a volume less than 25% of a subject's total lung capacity (TLC), as is the case for all protocols currently carried out under IND 109490
Primary outcome measures
- Pulmonary Vascular Remodeling [Time frame: 1 year]
Secondary outcome measures (4)
- RBC Oscillation Amplitude [Time frame: 1 year]
- 6 Minute Walk Distance [Time frame: 1 Year]
- NTproBNP [Time frame: 1 year]
- World Health Organization (WHO) Functional Class (FC) [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
Arm 1 -IPAH
- Age: 18-75 years
- WHO functional class 2 or 3
- Mean pulmonary artery pressures > 20 mmHg
- Pulmonary capillary wedge pressure ≤15 mmHg
- Pulmonary vascular resistance > 2 Wood Units (WU)
- No other cause identified for PAH
Arm 2 -PAH-CTD
- Age: 18-75 years
- WHO functional class (FC) 2 or 3
- Mean pulmonary artery pressures > 20 mmHg
- Pulmonary capillary wedge pressure ≤15 mmHg
- Pulmonary vascular resistance > 2 WU
- Diagnosis of connective tissue disease
Exclusion criteria
- PH other than Idiopathic PAH or PAH associated with CTD; any conditions that prevent the performance of 129Xe MRI scans will be excluded from the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Duke University Medical Center — Durham
Identifiers
NCT: NCT06104228 · Pro00113893