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| Name | Class |
|---|---|
| Xemed LLC | INDUSTRY |
The purpose of this study is to develop rapid MRI techniques for imaging the lung with hyperpolarized helium-3 gas as an inhaled contrast agent. These techniques will be piloted in adults and older children before testing them in younger children and infants. The purpose is to enable imaging of non-sedated infants by imaging so fast as to freeze motion.
he purpose of this study is to further develop the techniques to permit the imaging of infant lungs with hyperpolarized helium-3 MRI including techniques for acquisition in free breathing infants and infants on a ventilator. We have developed fast imaging techniques and obtained proof-of-concept data in infants as young as 2 months old. Many pediatric lung diseases including CF, bronchopulmonary dysplasia (BPD) and asthma have their origins in infancy so it would be desirable to be able to image infants with hyperpolarized gas MRI. We focused on developing fast imaging techniques to, in essence, freeze lung motion in non-sedated infants. We feel the technique will be more widely adopted if clinically useful images can be obtained without sedating the infant. Some very rapid imaging techniques have been developed for conventional proton MRI for applications such as cardiac MRI that require very short acquisition time. We modified these techniques for use in hyperpolarized gas MRI and developed a technique that permits the acquisition of the entire lung volume of an infant in less than 1 second. These techniques would also be useful for imaging infants who are still on a ventilator with the hope of increasing our understanding of lung development and neonatal lung disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperpolarized Helium 3 MRI of the chest | Experimental | Using hyperpolarized helium-3 as an inhaled contrast agent for MRI, we will assess the lung ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperpolarized Helium-3 MRI of the chest | Drug | hyperpolarized helium-3 is an inhaled gaseous contrast agent for MRI and permits the acquisition of high quality imagined of lung ventilation. |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilation Defects as Seen on Hyperpolarized Helium-3 MRI | On hyperpolarized helium-3 MRI, well ventilated areas of the lung appear bright and poorly ventilated areas appear dark. The poorly ventilated areas are called ventilation defects. Human readers looked at the hyperpolarized helium-3 MR images and determined whether the lungs had: No Defects, Small Defects, or Large Defects. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yun M Shim, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hyperpolarized Helium 3 MRI of the Chest | Using hyperpolarized helium-3 as an inhaled contrast agent for MRI, we will assess the lung ventilation. Hyperpolarized Helium-3 MRI of the chest: hyperpolarized helium-3 is an inhaled gaseous contrast agent for MRI and permits the acquisition of high quality imagined of lung ventilation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hyperpolarized Helium 3 MRI of the Chest | Using hyperpolarized helium-3 as an inhaled contrast agent for MRI, we will assess the lung ventilation. Hyperpolarized Helium-3 MRI of the chest: hyperpolarized helium-3 is an inhaled gaseous contrast agent for MRI and permits the acquisition of high quality imagined of lung ventilation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ventilation Defects as Seen on Hyperpolarized Helium-3 MRI | On hyperpolarized helium-3 MRI, well ventilated areas of the lung appear bright and poorly ventilated areas appear dark. The poorly ventilated areas are called ventilation defects. Human readers looked at the hyperpolarized helium-3 MR images and determined whether the lungs had: No Defects, Small Defects, or Large Defects. | 6 of the 44 imaged subjects were part of the technique development and were not included in the data analysis. | Posted | Count of Participants | Participants | Day 1 |
|
1 week
Patients or their family were contacted within 1 to 5 days after completion of imaging.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hyperpolarized Helium 3 MRI of the Chest | Using hyperpolarized helium-3 as an inhaled contrast agent for MRI, we will assess the lung ventilation. Hyperpolarized Helium-3 MRI of the chest: hyperpolarized helium-3 is an inhaled gaseous contrast agent for MRI and permits the acquisition of high quality imagined of lung ventilation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache/sore throat | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Talissa Altes, MD | University of Missouri | 573-882-1026 | altest@health.missouri.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2017 | Feb 17, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D001249 | Asthma |
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 5 |
| 44 |
| Fever | General disorders | Systematic Assessment |
|
| Upset Stomach/vomiting/gas | Gastrointestinal disorders | Systematic Assessment |
|
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D007235 | Infant, Premature, Diseases |