129 Xenon MRI as a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH)
Part of paid clinical trials in Durham, North Carolina.
- Sponsor
- Bastiaan Driehuys
- Study ID
- NCT06104228
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Connective Tissue Diseases
- Idiopathic Pulmonary Arterial Hypertension
- Pulmonary Arterial Hypertension
- Pulmonary Arterial Hypertension Associated With Connective Tissue Disease (Disorder)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- 129Xe Hyperpolarized — DRUGEach 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
Study Details
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).
Key Dates
- Start date
- Aug 12, 2024
- Status verified
- Feb 2026
- Primary completion
- Jan 1, 2027
- Completion
- Mar 31, 2027
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Other: Idiopathic Pulmonary Arterial HypertensionArm 1... patients with IPAH
- Other: Pulmonary Arterial Hypertension Associated with Connective Tissue DiseaseArm 2... patients with CTD-PAH
Primary Outcome Measure
Pulmonary Vascular Remodeling [ Time Frame: 1 year ]
Central Contacts
- Claudia Salazar+1 919 660 2026
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | Fawaz A Alenezi, MD (PRINCIPAL_INVESTIGATOR) |
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