NCT05041140

Hyperpolarized 129-Xenon Imaging in Adult Hematopoietic Cell Transplant Recipients With Pulmonary Impairment

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is designed to measure the correlation of hyperpolarized 129-Xe magnetic resonance imaging (129-XeMRI) in allogeneic hematopoietic cell transplant (allo-HCT) recipients at MD Anderson Cancer Center (MDACC) who develop bronchiolitis obliterans syndrome (BOS) or BOS stage 0p (pulmonary impairment not meeting the definition for BOS, defined below) and controls with chronic graft-versus-host disease (cGVHD). The primary objective of the study is to correlate 129-Xenon measures of ventilation, gas exchange, and pulmonary circulation with spirometric and quantitative CT measurements. A secondary objective is to determine whether measurement of 129-Xe MRI characteristics in patients with BOS stage 0p can predict BOS progression 6 months after enrollment.

Detailed description

The primary objective of the study is to correlate 129-Xenon measures of ventilation, gas exchange, and pulmonary circulation with spirometric and quantitative CT measurements. A secondary objective is to assess the differences in 129-Xe MRI characteristics between patients with and without OS progression at 6 months after enrollment. Other secondary objectives include the assessment of the relationship of VDP, barrier defects (continuous variable), and circulation defects (continuous variable) with pulmonary function, quantitative CT measurements, SGRQ, and SF-6D.

Conditions

• Pulmonary
• Pneumonia
• Hematopoietic System--Cancer

Interventions

Type	Name	Description
DEVICE	29-XeMRI imaging	129-XeMRI scan

Timeline

• Start date: 2024-08-14
• Primary completion: 2027-07-20
• Completion: 2027-07-20
• First posted: 2021-09-10
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study