NCT05041140 Hyperpolarized 129-Xenon Imaging in Adult Hematopoietic Cell Transplant Recipients With Pulmonary Impairment
| NCT ID | NCT05041140 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Pulmonary |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-08-14 |
| Primary Completion | 2027-07-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2024-08-14 with a primary completion date of 2027-07-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Ajay Sheshadri
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT05041140 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05041140 currently recruiting?
Yes, NCT05041140 is actively recruiting participants. Contact the research team at asheshadri@mdanderson.org for enrollment information.
Where is the NCT05041140 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05041140 clinical trial?
NCT05041140 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Ajay Sheshadri at M.D. Anderson Cancer Center. The trial plans to enroll 25 participants.