Assessing Response to Inhaled Prostacyclin With Hyperpolarized Xe MRI

Pro00086282

This study seeks to deploy several forms of 129Xe MRI contrast as well as emerging conventional proton MRI techniques 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 too test gas exchange dynamics with high temporal resolution. The conventional 1H MRi scans will include a free-breathing ultra-short echo time scan that provides images similar to that of a CT scan. This will be done pre, immediately post, and 2-4 hours post inhaled prostacyclin therapy.

2018-03-29

2022-10-31

2022-11-01

Completed

Early phase I

11

Inclusion Criteria: Patients with known Pulmonary Hypertension on treatment with inhaled prostacyclin (iTRE) that are followed in the Duke Pulmonary Vascular Disease Clinic. Inclusion criteria includes: Group 1 PH (mPAP ≥ 25 mmHg, PCWP ≤ 15 mmHg in the absence of significant concomitant left heart disease or lung disease), out-of-proportion Group 3 PH (mPAP ≥ 25 mmHg, PCWP ≤ 15 mmHg with PVR ≥ 5 WU and evidence of right heart failure in the setting of lung disease), maintenance on a stable, well-tolerated treatment dose of iTRE (ideally ≥ 8 breaths QID) Exclusion criteria: Pregnant women were excluded from this study. Women of childbearing potential must have a negative urine pregnancy test in order to participate in this study. Definition of Women of CBP: The median age of menopause in the US, defined as 12 months of amenorrhea, is 51 years; by age 48, approximately 15% of women will be postmenopausal, while virtually 100% will be post-menopausal by age 53. Women are considered past the age of "child-bearing potential" if * they are greater than 55 years of age, OR * they are at least 50 years of age AND o have not menstruated for at least 12 months, OR * have a documented Follicule Stimulating Hormone (FSH) level of greater than 40 mIU/mL. * they are at least 45 years of age AND o have not menstruated for at least 18 months, OR * have a documented Follicule Stimulating Hormone (FSH) level of greater than 40 mIU/mL.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This will be a single-blinded open-label study enrolling 15 patients (accrued 12 subjects total) with Pulmonary Hypertension who are currently on a stable dose of Inhaled Prostacyclin for treatment of PH.', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The outcomes assessor, the radiologist who is reading the imaging will be blinded to treatment.'}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}

2023-10-18