HP 129Xe MRI for Evaluation of CLAD in Lung Transplant Recipients

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05550662

Collaborator

University Health Network, Toronto (Other)

Enrollment

Location

Arm

11.5

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the feasibility of hyperpolarized 129Xe MRI in lung transplant recipients and assess structural and functional pulmonary changes using hyperpolarized 129Xe MRI

Condition or Disease	Intervention/Treatment	Phase
Lung Transplant Rejection	Drug: 129Xenon	Phase 2

Detailed Description

Lung transplantation is an effective treatment for end-stage lung disease. However, median survival post-LTx is 6 years. This is primarily due to chronic lung allograft dysfunction (CLAD).

Clinical management of LTx recipients is focused on identifying early risk factors for CLAD, by monitoring graft function with spirometry and transbronchial biopsies. However, both have significant limitations.

Hyperpolarized (HP) noble gas lung MRI (3He and 129Xe) allows mapping of both lung anatomy and function. 129Xe-MRI could provide a diagnostic tool that is able to detect CLAD more sensitively and earlier than the current gold standard measurements of spirometry and plethysmography, and thus allow a means to detect and prevent /slow down irreparable and irreversible damage to the lungs in the early stages of disease.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

We will map lung ventilation (V), perfusion (Q), apparent diffusion coefficient (ADC) and gas exchange using 129Xe MRI in 15 LTx recipients. All MRI scans will be acquired in one visitWe will map lung ventilation (V), perfusion (Q), apparent diffusion coefficient (ADC) and gas exchange using 129Xe MRI in 15 LTx recipients. All MRI scans will be acquired in one visit

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Hyperpolarized 129Xe Magnetic Resonance Imaging for Evaluation of Chronic Lung Allograft Dysfunction in Lung Transplant Recipients

Anticipated Study Start Date :

Jan 15, 2023

Anticipated Primary Completion Date :

Oct 15, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single arm Participants will inhale hyperpolarized 129Xe gas.	Drug: 129Xenon There is no study medication evaluated. As part of the MRI, participants will inhale hyperpolarized 129Xe gas at a dose of up to 1/6th of total lung capacity (TLC) (lung volume), mixed with nitrogen to a total volume of 1.5 L. The polarized 129Xe will be inhaled in a single breath-hold. This is intended to fill the lungs gas, allowing for lung MRI. Other Names: Hyperpolarized Xenon Gas

Arm

Intervention/Treatment

Experimental: Single arm

Participants will inhale hyperpolarized 129Xe gas.

Drug: 129Xenon

There is no study medication evaluated. As part of the MRI, participants will inhale hyperpolarized 129Xe gas at a dose of up to 1/6th of total lung capacity (TLC) (lung volume), mixed with nitrogen to a total volume of 1.5 L. The polarized 129Xe will be inhaled in a single breath-hold. This is intended to fill the lungs gas, allowing for lung MRI.

Other Names:

Hyperpolarized Xenon Gas

Outcome Measures

Primary Outcome Measures

129Xe-MRI [1 year]
Ventilation defect percent (VDP)

Secondary Outcome Measures

1H-MRI [1 year]
Structural features

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients, deemed clinically stable by the lung transplant team at UHN Toronto Lung Transplant Program (TLTP), 18 years of age or older
Double lung transplant recipient
For the 5 CLAD-free participants - at least 1 year of follow-up post-LTx and no substantial and persistent FEV1 decline (as per the ISHLT CLAD definition).
For the 10 participants with CLAD - prior diagnosis of CLAD made by the clinical team (member of the TLTP).
PFT measurements within 1 month of scan visit.
FEV1 > 1.0 L

Exclusion Criteria:

Currently pregnant or lactating
Psychiatric or addictive disorders that would preclude obtaining informed consent or adherence to protocol
Inability to travel to obtain MRI scan
Any contraindications to MRI including but not limited to severe claustrophobia, implanted devices, aneurysm clips, neurostimulators (patients will be prescreened prior to registration).
Baseline oxygen saturation of less than 88%.
Requiring supplemental oxygen at baseline

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8

Sponsors and Collaborators

The Hospital for Sick Children
University Health Network, Toronto

Investigators

Principal Investigator: Giles Santyr, PhD, The Hospital for Sick Children

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Giles Santyr, Dr Giles Santyr (PhD), The Hospital for Sick Children

ClinicalTrials.gov Identifier:

NCT05550662

Other Study ID Numbers:

1000078240

First Posted:

Sep 22, 2022

Last Update Posted:

Dec 9, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Giles Santyr, Dr Giles Santyr (PhD), The Hospital for Sick Children

Lung MRI

129Xenon

Lung transplant recipient

Chronic lung allograft dysfunction

Additional relevant MeSH terms:

Xenon

Study Results

No Results Posted as of Dec 9, 2022