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NCT05041140 Clinical Trial

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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05041140
Other study ID # 2020-1170
Secondary ID NCI-2021-09252
Status Recruiting
Phase
First received
Last updated
Start date July 5, 2022
Est. completion date July 20, 2025

Study information
Verified date February 2024
Source M.D. Anderson Cancer Center
Contact Ajay Sheshadri
Phone (713) 563-1987
Email asheshadri@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date July 20, 2025
Est. primary completion date July 20, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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: 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 29-XeMRI imaging
129-XeMRI scan

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To correlate 129-Xenon measures of ventilation, gas exchange, and pulmonary circulation with spirometric and quantitative CT measurements. through study completion, an average of 1 year
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