Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
and 4) the speed of depolarization lets us measure the partial pressure of oxygen and associated gas exchange mechanisms.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group One: Prone MRI Scans | Experimental | Subjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan |
|
| Group Two: Supine MRI scans | Active Comparator | Subjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prone hyperpolarized 3 helium gas scan | Drug | Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, measurements completed at one day visit only. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric A Hoffman, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only supine MRI subjects were recruited
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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. | Only Supine MRI's were performed. ADC values at 20%, 60% and 100% vital capacity (VC) were compared against each other. | Posted | Mean | Standard Deviation | ADC (cm2/sec) | Through study completion, measurements completed at one day visit only. |
|
Through study completion, an average of 2 weeks.
There were no adverse events reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Hoffman | University of Iowa | (319) 356-1381 | eric-hoffman@uiowa.edu |
Not provided
| ID | Term |
|---|---|
| D003287 | Contrast Media |
| D012129 | Respiratory Function Tests |
| ID | Term |
|---|---|
| D064907 | Diagnostic Uses of Chemicals |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Supine hyperpolarized 3 helium gas scan | Drug | Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine. |
|
|
| Vitals | Diagnostic Test |
|
| Pulmonary Function Tests | Diagnostic Test | Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes |
|
| Initial protocol MRI scan | Diagnostic Test | Initial scan to determine placement |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 18 | 0 | 18 | 0 | 18 |
Not provided
Not provided
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |