- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04941573
Hyperpolarized MRI of Lung Transplants
Hyperpolarized 129 Xenon MRI in a Pediatric Population With Lung Transplant
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective interventional study of 15 evaluable pediatric patients following a lung transplant that will be studied at the Children's Hospital of Philadelphia in association with the functional and metabolic imaging group of the Perelman School of Medicine from the University of Pennsylvania. Potential subjects will be identified by their pediatric pulmonologist during the follow-up clinic visit for referral to the study. These patients are part of the Lung Transplant Program at CHOP. Before discussing participation in the study, potential subjects will be screened using the protocol inclusion and exclusion criteria. Participation will be discussed between the PI and the referring pediatric pulmonologist. Participation will be discussed with the parents/guardian by the pediatrician and/or radiologist after identification and confirmation of eligibility. Consent will be obtained at the physician's office prior to imaging. A total of approximately 20 patients with ages 8-20 years will be recruited and enrolled to produce up to 15 evaluable subjects.
Hyperpolarized xenon is a novel contrast agent for imaging human lungs using non-invasive Magnetic Resonance Imaging for producing high quality 3D maps of lung structure and function. The xenon gas is inhaled by the subject while inside the MRI scanner and during a short breath-hold the image is acquired. Different MRI techniques can be used to provide regional lung function and structure such as: ventilation, local alveolar oxygen concentration (PAO2) and oxygen uptake rate, apparent diffusion coefficient (ADC), etc. Xenon is soluble in lung tissue and blood with a Chemically Shifted MRI resonant frequency, property which can be quantified through MRI into maps and global parameters related to lung parenchyma and blood exchange.
Early detection of lung transplant complications, such as CLAD, can have life-saving benefit for patients. CLAD is usually diagnosed by spirometry measurements, which are typically not sensitive until late onset of the disease. Longitudinal studies and patient monitoring using HRCT is not desirable due to ionizing radiation and potential long term health hazards. Also, HRCT detects only structural changes of the lung tissue and airways. HP xenon MRI can detect ventilation defects and abnormal gas exchange, which likely can be more sensitive to incipient abnormal lung function.
This study is designed as an open label longitudinal study. Post lung transplant pediatric patients will have two sessions of HP xenon MRI separated by six months. Following parental or legally authorized representative informed consent, the subjects will undergo HP Xenon MR imaging that will be performed in an MRI scanner in at the Hospital of the University of Pennsylvania. Additional conventional proton images of the chest are typically acquired for localization and to assist with interpreting the xenon MR images. These are acquired at the same time and space. After six months, the participant will undergo another hyperpolarized gas MRI as described above to evaluate their progress and evolution.
HP Xenon MRI data will provide high resolution 3D information about the ventilation, oxygen exchange (PAO2), and structural integrity of the alveoli and small airways (ADC). Gas exchange and transport will be assessed from property of xenon to dissolve in lung parenchyma and blood. The signal of the xenon dissolved in the lung tissue and blood compared to the signal of the xenon within the airspaces can be used to extract the septal wall thickness and capillary transit time in the pulmonary vasculature. Data will be used for evaluation of patients for potential lung transplant complications, such as Chronic Lung Allograft Dysfunction (CLAD). This is a longitudinal clinical study. Investigators will study correlations of HP Xenon MRI metrics with CT images and spirometry.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: David M Biko, MD
- Phone Number: 267-425-7189
- Email: bikod@email.chop.edu
Study Contact Backup
- Name: Rahim Rizi, PhD
- Phone Number: 215-615-2426
- Email: rizi@uphs.upenn.edu
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Children's Hospital of Philadelphia
-
Contact:
- David M Biko, MD
- Phone Number: 267-425-7189
- Email: bikod@email.chop.edu
-
Contact:
- Rahim Rizi, PhD
- Phone Number: 215-615-2426
- Email: rizi@uphs.upenn.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males or females age 8 - 20 years of age at enrollment
- Subjects with history of lung transplant
- Available clinically indicated pulmonary function test
Exclusion Criteria:
- Any contraindication to the safe performance of MRI (metallic foreign bodies, non-safety rated implanted devices including but not limited to vascular clips, pacemaker, stent, infusion pump, neuro-stimulator, prosthesis)
- Subject unable to perform a spirometry
- Individuals requiring conscious sedation or anesthesia
- Severe claustrophobia
- Pregnant females
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hyperpolarized Xenon MRI for lung transplant diagnosis
All post lung transplant patients will undergo hyperpolarized 129-Xenon MRI and conventional proton MR imaging of the lung. Recent HRCT and spirometry measurements as part of clinical care will be available in the medical history for comparison. There will be multiple administered inhalation of HP Xenon during an imaging session. Maps of xenon ventilation (distribution) will be used for analyzing function of the lungs. These maps will be compared against 3D high-resolution CT images for regional correlations, and against spirometry as global measurements of lung health status. Additionally, xenon dissolved in lung parenchyma and blood, allows for measurement of gas exchange properties. Each subject will have a secondary imaging session after six-months for evaluating potential changes in the lung function and early detection of lung transplant complications such as CLAD. |
Hyperpolarized xenon is a contrast imaging agent for lung MR imaging.
Inert noble gas xenon is hyperpolarized using Xemed developed technology.
The gas is administered to the human subjects as a short seconds-long breath-hold while inside the MRI scanner.
Once the gas is inhaled, lung images of HP Xenon distributed within the lung spaces can be acquired.
Additionally, xenon follows a similar path to oxygen, dissolving in lung tissue and further in bloodstream.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Ventilation Defect Percent (VDP) from baseline to 6-month follow-up.
Time Frame: baseline to 6-month follow-up
|
129Xe MRI can reveal unventilated regions of the lungs where the gas cannot reach after being inhaled.
|
baseline to 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in oxygen partial pressure (PAO2) maps from baseline to 6-month follow-up.
Time Frame: baseline to 6-month follow-up
|
Oxygen partial pressure (PAO2) maps can be extracted from 129Xe MRI maps in a single breath-hold.
Regions of the lungs that show abnormal PAO2 values are susceptible of improper ventilation or gas exchange.
|
baseline to 6-month follow-up
|
Changes in gas exchange to lung tissue and blood and transport coefficient maps from baseline to 6-month follow-up.
Time Frame: baseline to 6-month follow-up
|
Xenon is soluble in lung tissue and blood presenting specific MRI frequencies and this property can be used for imaging gas exchange properties at the alveolar level.
|
baseline to 6-month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David M Biko, MD, Children's Hospital of Philadelphia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-015796
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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