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NCT Number: NCT05041140

Hyperpolarized 129-Xenon Imaging in Adult Hematopoietic Cell Transplant Recipients With Pulmonary Impairment

This study is designed to measure the correlation of hyperpolarized 129-Xe magnetic resonance imaging (129-XeMRI) in allogeneic hematopoietic cell transplant (allo-HCT) recipients at MD Anderson Cancer Center (MDACC) who develop bronchiolitis obliterans syndrome (BOS) or BOS stage 0p (pulmonary impairment not meeting the definition for BOS, defined below) and controls with chronic graft-versus-host disease (cGVHD).

The primary objective of the study is to correlate 129-Xenon measures of ventilation, gas exchange, and pulmonary circulation with spirometric and quantitative CT measurements.

A secondary objective is to determine whether measurement of 129-Xe MRI characteristics in patients with BOS stage 0p can predict BOS progression 6 months after enrollment.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Ajay Sheshadri

CONTACT

About this study

The primary objective of the study is to correlate 129-Xenon measures of ventilation, gas exchange, and pulmonary circulation with spirometric and quantitative CT measurements.

A secondary objective is to assess the differences in 129-Xe MRI characteristics between patients with and without OS progression at 6 months after enrollment. Other secondary objectives include the assessment of the relationship of VDP, barrier defects (continuous variable), and circulation defects (continuous variable) with pulmonary function, quantitative CT measurements, SGRQ, and SF-6D.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Allo-HCT recipients who are at least 18 years of age and have BOS (n=10 patients), BOS 0p (n = 10 patients), or cGVHD of a non-lung organ without evidence of pulmonary impairment (n = 5 patients).

Healthy Cohort - Inclusion Criteria:

We will perform only XeMRI imaging on 10 healthy adult (18 years and older) volunteers with no medical issues for technical calibration of the XeMRI technology. Members of the study team may serve as healthy volunteers if they have no prior history of lung disease. These data will not be included as part of the analysis.

Exclusion criteria

  • Participants unable to follow up at MD Anderson for routine clinical care
  • Inability or unwillingness to give informed consent
  • Relapsed disease or life expectancy less than 6 months at time of enrollment
  • Severe claustrophobia precluding MRI imaging
  • Active pulmonary infection
  • Pregnant women

Treatment and study plan

29-XeMRI imaging

Device

129-XeMRI scan

Primary outcomes

  1. To correlate 129-Xenon measures of ventilation, gas exchange, and pulmonary circulation with spirometric and quantitative CT measurements.

    Time frame: through study completion, an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Ajay Sheshadri

CONTACT

[email protected]

(713) 563-1987

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2021
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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