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

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

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-14

Study Completion Date

2027-07-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pulmonary Pneumonia Hematopoietic System--Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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29-XeMRI imaging

129-XeMRI scan

Intervention Type DEVICE

Eligibility Criteria

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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).

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes