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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-07

Study Completion Date

2024-08-02

Brief Summary

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

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Detailed Description

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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.

Conditions

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Lung Transplant Rejection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 visit

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Single arm

Participants will inhale hyperpolarized 129Xe gas.

Group Type EXPERIMENTAL

129Xenon

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Hyperpolarized Xenon Gas

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes