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NCT04941573 · ClinicalTrials.gov registry record

Assessment of Chronic Lung Allograft Dysfunction Using Single-breath & Multi-breath Hyperpolarized Xenon-129 MRI

A clinical trial, sponsored by Xemed.

Terminated
Registry status
45
Enrollment target

NCT04941573: Clinical Trial study, sponsored by Xemed.

NCT04941573 is a clinical trial that was terminated before completion, run by Xemed. The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04941573 was terminated before completion, sponsored by Xemed.

TERMINATED
Registry status
45 participants
Enrollment target

Study Summary

This study will use Magnetic Resonance Imaging (MRI) to study the lungs of 90 volunteers using the inhaled contrast agent, hyperpolarized xenon-129. Once inhaled, this gas can provide information to imagers regarding lung functionality across specific regions of the lungs by assessing the replacement of air during the normal breathing cycle, how much oxygen is in the airspaces, and if the natural spongy tissue structure has been compromised by lung disease. Of the 90 subjects, 70 will be patients who received lung transplantation from the Penn/Temple Lung Transplant Teams and are receiving follow up treatment at HUP or TUH, 10 will be healthy control subjects who participated favorably in our HP 129Xe imaging protocol, and 10 will be patients who have been diagnosed with chronic obstructive pulmonary disease (COPD)-preferentially recruited from the Temple University COPDGene cohort, who have never undergone a lung transplant. 20 of the lung transplant recipient subjects will be patients who have received a recent clinical diagnosis of chronic lung allograft dysfunction (CLAD) prior to enrollment in our study, while the other 50 will have recently undergone their initial transplant surgery at the time of enrollment.

Primary Outcome

The primary endpoint is the number and extent of functional and microstructural abnormalities observed in the lung transplant recipients following inhalation of polarized 129Xe. For the single-breath protocol, images will be obtained immediately after inhalation and during the subsequent breath hold. During the multi-breath protocol, images will be obtained during a \<1 second breath hold at the end of the exhalation. Fractional ventilation will be obtained based on the signal build up for multi

Interventions

  • COMBINATION_PRODUCT Hyperpolarized 129-Xenon (MagniXene) MRI of the lung

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2021-01-19
Est. Completion 2025-09-04
Xemed

5 total trials

Why NCT04941573 stopped before completion

NCT04941573 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Hyperpolarized 129-Xenon (MagniXene) MRI of the lung is the first listed.

NCT04941573 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04941573 about?

NCT04941573 is a clinical study titled "Assessment of Chronic Lung Allograft Dysfunction Using Single-breath & Multi-breath Hyperpolarized Xenon-129 MRI". This study will use Magnetic Resonance Imaging (MRI) to study the lungs of 90 volunteers using the inhaled contrast agent, hyperpolarized xenon-129. Once inhaled, this gas can provide information to imagers regarding lung functionality across specific regions of the lungs by assessing the replacemen...

What is the current status of trial NCT04941573?

This trial is currently terminated. The enrollment target is 45 participants. The study started on 2021-01-19. Estimated completion is 2025-09-04.

What interventions are being tested in trial NCT04941573?

The interventions under investigation include: Hyperpolarized 129-Xenon (MagniXene) MRI of the lung (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT04941573?

This trial is sponsored by Xemed, which has 5 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04941573, the US trial registry maintained by the National Library of Medicine. NCT04941573 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.