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

NCT05041140 | Recruiting DMC FDA Device

• 2 other identifiers: 2020-1170NCI-2021-09252
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary; Pneumonia; Hematopoietic System--Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

29-XeMRI imaging DEVICE

129-XeMRI scan

Eligibility Criteria

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

Study Population

Healthy Population

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ajay Sheshadri

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajay Sheshadri

CONTACT

(713) 563-1987; asheshadri@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 10, 2021
• Study Start: August 14, 2024
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): July 20, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)