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

NCT05550662 | Terminated Phase 2

• 1 other identifier: 1000078240
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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

Conditions

Lung Transplant Rejection

Keywords

Lung MRI; 129Xenon; Lung transplant recipient; Chronic lung allograft dysfunction

Outcome Measures

Primary Outcomes (1)

• 129Xe-MRI

  Ventilation defect percent (VDP)

  1 year

Secondary Outcomes (1)

• 1H-MRI

  1 year

Study Arms (1)

Single arm

EXPERIMENTAL

Participants will inhale hyperpolarized 129Xe gas.

Drug: 129Xenon

Interventions

129Xenon 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.

Also known as: Hyperpolarized Xenon Gas

Single arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• University Health Network, Toronto: collaborator

Study Sites (2)

Hospital for Sick Chilldren

Toronto, Ontario, M5G 1X8, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Study Officials

• Giles Santyr, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Giles Santyr (PhD)

Model Details: 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

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: February 7, 2024
• Primary Completion: August 2, 2024
• Study Completion: August 2, 2024
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)