NCT04029636

Hyperpolarized 129Xe MRI for the Assessment of BOS With Late Onset LONIPC

Hyperpolarized 129Xe Magnetic Resonance Imaging for the Early Detection of Bronchiolitis Obliterans Syndrome (BOS) and Other Late Onset Non-infectious Pulmonary Complications (LONIPCs) Following Hematopoietic Stem Cell Transplantation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 45 (estimated)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The development of bronchiolitis obliterans syndrome (BOS) and other late onset non-infectious pulmonary complications (LONIPCs) following hematopoietic stem cell transplantation (HSCT) is associated with a significantly worse prognosis, high disease burden, and excessive health resource utilization. In this proposal, the investigators plan to examine and compare different diagnostic modalities which can provide detailed physiological and anatomical characterization of LONIPCs.

Detailed description

There is mounting evidence suggesting that current practice is failing to provide early detection of LONIPCs, before critical loss of lung function occurs. Furthermore, autopsy series in HSCT patients have revealed a wide spectrum of pulmonary pathology in different compartments of the lung (airway, parenchyma, interstitium) within the same individual. These findings imply that LONIPCs and the extent of their pulmonary involvement are under-recognized, which adversely impacts the clinical trajectory and outcomes of HSCT patients. These findings also suggest that the underlying pathophysiology is multi-faceted and diffuse, highlighting a need for a multi-modal approach to early detection, and better characterization of the spectrum of pulmonary involvement. In this study, we plan to examine and compare different diagnostic modalities which can provide detailed physiological and anatomical characterization of LONIPCs. We propose an observational study using hyperpolarized magnetic resonance imaging (MRI) to capture the anatomical and functional spectrum of LONIPCs post-HSCT. Hyperpolarized magnetic resonance imaging (MRI) is a novel and noninvasive functional imaging method, with the capacity to evaluate pulmonary structure and function. Inhaled hyperpolarized gas (129Xenon) maps focal areas of ventilation defects, a functional consequence of small airway obstruction, which often goes undetected on PFT in early disease states. It can provide additional information on alveolar structure and gas diffusion, lending insight into pathology in other compartments. Oscillometry technique (FOT) is a non-invasive technique using wave frequency to map out large and small airways, commonly used in pediatric pulmonology. We propose to examine the 2 novel modalities in HSCT patients with and without LONIPC/BOS. We hypothesize that the use of functional-structural imaging and FOT will provide better characterization and the extent of LONIPCs in early diseases states post-HSCT. These findings will provide invaluable insight into the pathophysiology of LONIPCs, providing a platform for future research into the early diagnosis and treatment of these high-burden diseases.

Conditions

• Bronchiolitis Obliterans

Interventions

Type	Name	Description
OTHER	Inhaled Hyperpolarized Xenon-129	How hyperpolarized 129Xe MRI measurements of lung structure and function change over time in a population at high risk for LONIPC related to their transplant

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-08-01
• Completion: 2021-11-01
• First posted: 2019-07-23
• Last updated: 2019-07-23

Locations

1 site across 1 country: Canada