NCT01280994 Hyperpolarized 129Xe MRI for Imaging Pulmonary Function
| NCT ID | NCT01280994 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Bastiaan Driehuys |
| Condition | Interstitial Lung Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 445 participants |
| Start Date | 2011-01 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 445 participants in total. It began in 2011-01 with a primary completion date of 2030-12.
⚠ 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
The purpose of this study is to develop and evaluate the usefulness of MRI using 129Xe gas for regional assessment of pulmonary function. Specifically, three forms of 129Xe MRI contrast will be the investigators focus - 1) imaging of the 129Xe ventilation distribution, 2) imaging the alveolar microstructure via the 129Xe apparent diffusion coefficient (ADC), and 3) imaging 129Xe that dissolves in the pulmonary blood and tissues upon inhalation. Such imaging of 129Xe gas transfer is expected to be uniquely sensitive to pathologies affecting gas exchange (fibrosis, emphysema, pulmonary hypertension) and provide new insights regarding the normal resting heterogeneity of pulmonary gas exchange.
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria for Healthy Control Subjects 1. Subject has no diagnosed pulmonary conditions 2. Subject has not smoked in the previous 5 years. 3. Smoking history, if any, is less than or equal to 5 pack-years. Inclusion Criteria for Subjects with lung disease 1. Subject has a diagnosis of pulmonary dysfunction made by a physician 2. No acute worsening of pulmonary function in the past 30 days Exclusion Criteria: 1. Subject is less than 18 years old 2. MRI is contraindicated based on responses to MRI screening questionaire 3. Subject is pregnant or lactating 4. Respiratory illness of a bacterial or viral etiology within 30 days of MRI 5. Subject has received an investigational medicinal product (not including 129Xe) within 30 days of MRI 6. Subject has any form of known cardiac arrhythmia 7. Subject does not fit into 129Xe vest coil used for MRI 8. Subject cannot hold his/her breath for 15 seconds 9. Subject deemed unlikely to be able to comply with instructions during imaging
Contact & Investigator
Joseph Mammarappallil, M.D.
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT01280994 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Interstitial Lung Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01280994 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT01280994 currently recruiting?
Yes, NCT01280994 is actively recruiting participants. Contact the research team at jennifer.korzekwinski@duke.edu for enrollment information.
Where is the NCT01280994 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT01280994 clinical trial?
NCT01280994 is sponsored by Bastiaan Driehuys. The principal investigator is Joseph Mammarappallil, M.D. at Duke University. The trial plans to enroll 445 participants.