Radiation Exposure
Conditions
Brief summary
The main purpose of this study is to assess and test the reproducibility and results of hyperpolarized 3-Helium gas as a contrast agent with Magnetic Resonance Imaging (MRI) of the lungs in healthy adult subjects.
Detailed description
New CT imaging techniques often expose the patient to higher doses of radiation. There is a great deal of concern about effects of medical radiation exposure on the general public and regulations are becoming stricter on the radiation doses that are allowed. One novel procedure that has been developed to evaluate the function and structure of the lung is the use of hyperpolarized gases with MRI scanners. We want to compare the lung imaging techniques that we have developed in our lab to a technique that uses hyperpolarized 3-Helium gas with MRI. This technique is free from radiation and less invasive than many lung imaging techniques. Hyperpolarized gas MRI is based on the introduction of spins into the lungs, allowing imaging to take place. The use of hyperpolarized 3-Helium has a few advantages: 1. it allows us to see the microstructure of the lungs through diffusion imaging (apparent diffusion coefficient) which correlates with the size of airways and alveolar space. 2. it allows us to see ventilation, or how air moves in the lungs, at a high resolution. 3. it is capable of ultra fast imaging which will help us assess gas flow patterns within the airways. and 4) the speed of depolarization lets us measure the partial pressure of oxygen and associated gas exchange mechanisms.
Interventions
DRUGProne hyperpolarized 3 helium gas scan
Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone.
DRUGSupine hyperpolarized 3 helium gas scan
Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine.
DIAGNOSTIC_TESTVitals
DIAGNOSTIC_TESTPulmonary Function Tests
Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes
DIAGNOSTIC_TESTInitial protocol MRI scan
Initial scan to determine placement
Sponsors
Eric A. Hoffman
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* must be between the ages of 18 and 90 * must have a Body Mass Index (BMI) of \< 32 and weigh \< 200 lbs.
Exclusion criteria
* if female, must not be pregnant or breastfeeding * must not have any metal objects in or on their body including body piercings that cannot be easily removed, bullets, metallic fragments or slivers in eyes, skin, etc., pacemaker or defibrillation, aneurysm clips, cochlear implants, coronary stents, or neurostimulation. * must not have a history of claustrophobia, panic disorders, anxiety attacks, atrial fibrillation, uncontrolled high blood pressure, frequent ventricular ectopic rhythm, hemodynamic instability, kidney dysfunction or heart disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels. | Through study completion, measurements completed at one day visit only. | Validate the intrinsic variability of ADC (cm2/s) as a function of normal procedural and physiological changes in an attempt to standardize the use of the biomarker in future assessments of pulmonary pathologies. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group One: Prone MRI Scans Subjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan
Prone hyperpolarized 3 helium gas scan: Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone.
Vitals
Pulmonary Function Tests: Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes
Initial protocol MRI scan: Initial scan to determine placement | 0 |
| Group Two: Supine MRI Scans Subjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan
Supine hyperpolarized 3 helium gas scan: Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine.
Vitals
Pulmonary Function Tests: Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes
Initial protocol MRI scan: Initial scan to determine placement | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Group One: Prone MRI Scans | Group Two: Supine MRI Scans | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 17 Participants | 17 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | — | 18 participants | 18 participants |
| Sex: Female, Male Female | — | 8 Participants | 8 Participants |
| Sex: Female, Male Male | — | 10 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 18 |
| other Total, other adverse events | 0 / 0 | 0 / 18 |
| serious Total, serious adverse events | 0 / 0 | 0 / 18 |
Outcome results
Primary
Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels.
Validate the intrinsic variability of ADC (cm2/s) as a function of normal procedural and physiological changes in an attempt to standardize the use of the biomarker in future assessments of pulmonary pathologies.
Time frame: Through study completion, measurements completed at one day visit only.
Population: Only Supine MRI's were performed. ADC values at 20%, 60% and 100% vital capacity (VC) were compared against each other.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Two: Supine MRI Scans | Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels. | 20% VC | 0.167 ADC (cm2/sec) | Standard Deviation 0.018 |
| Group Two: Supine MRI Scans | Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels. | 60% VC | 0.175 ADC (cm2/sec) | Standard Deviation 0.015 |
| Group Two: Supine MRI Scans | Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels. | 100% VC | 0.188 ADC (cm2/sec) | Standard Deviation 0.02 |
Comparison: We hypothesized that the anisotropic deformation index (ADC) is dependent upon lung inflation level. (Thus, it is important to standardize lung inflation when using this method)p-value: <0.001ANOVA