Phase 2 N=11 Diagnostic

Assessing Response to Inhaled Prostacyclin With Hyperpolarized Xe MRI

Pulmonary Vascular Disease

Bottom Line

View on ClinicalTrials.gov: NCT03367312 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2023

Primary outcome: Primary: Percent Change in Abnormal RBC Percentage — -17.7 percent change

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Hyperpolarized 129Xenon gas (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bastiaan Driehuys
Primary completion: Oct 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Abnormal RBC Percentage	-17.7	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03367312). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.