Assessing Response to Inhaled Prostacyclin With Hyperpolarized Xe MRI

NCT03367312 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Pro00086282
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Vascular Disease

Outcome Measures

Primary Outcomes (1)

• Percent Change in Abnormal RBC Percentage

  Percent change in pulmonary gas exchange (percent change in abnormal RBC percentage - calculated as: 100\*(value at 3 hours - value at baseline)/value at baseline) in patients with PH treated with inhaled prostacyclin.

  3 hours

Study Arms (1)

Pulmonary Hypertension Patients on Inhaled Prostacyclin

EXPERIMENTAL

10 subjects will Pulmonary Hypertension on a stable dose of Inhaled Prostacyclin for treatment of PH.

Drug: Hyperpolarized 129Xenon gas

Interventions

Hyperpolarized 129Xenon gas DRUG

Hyperpolarized 129Xenon gas XeMRI scans will provide 3D images of ventilation and gas exchange pre, post, and 2-4 hours post inhaled prostacyclin treatment. Subjects will inhale HP 129Xe from the dose delivery bags with each scan and then move into the scanner and undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will undergo several MRI scans after inhalation of HPXe. This will occur as three scans at the three different time points (pre, post, and 2-4 hours post) of inhaled prostacyclin treatment.

Also known as: Xe MRI

Pulmonary Hypertension Patients on Inhaled Prostacyclin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bastiaan Driehuys: lead
• United Therapeutics: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Results Point of Contact

• Title: Dr. Sudarshan Rajagopal
• Organization: Duke University School of Medicine

sudarshan.rajagopal@duke.edu

919-684-6237

Study Officials

• Sudarshan Rajagopal, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Bastiann Driehays, PhD

  Duke University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: The outcomes assessor, the radiologist who is reading the imaging will be blinded to treatment.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Duke University Medical Center

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 8, 2017
• Study Start: March 29, 2018
• Primary Completion: October 31, 2022
• Study Completion: November 1, 2022
• Last Updated: October 18, 2023
• Results First Posted: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)