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 — DRUG
    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

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 Hypertension
    Arm 1... patients with IPAH
  • Other: Pulmonary Arterial Hypertension Associated with Connective Tissue Disease
    Arm 2... patients with CTD-PAH

Primary Outcome Measure

Pulmonary Vascular Remodeling [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
David Ptashnik
9196682642
Fawaz A Alenezi, MD (PRINCIPAL_INVESTIGATOR)

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