Healthy VolunteersPhase 1NCT02995590
Assessing Deformable Image Registration in the Lung Using Hyperpolarized-gas MRI
A Phase 1 study testing Hyperpolarized He3 in people with Healthy Volunteers, run by University of Virginia at 1 site in United States.
Trial summary
Recently, the investigators have demonstrated a novel hyperpolarized helium tagging Magnetic Resonance Image (MRI) technique that is capable of directly, in vivo, and non-invasively measuring physiological lung deformation on a regional basis. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Hyperpolarized He3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 15 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All subjects must be willing to participate and undergo the procedure, and be manageable as out-patients.
- Normal Subjects: Currently feeling well without respiratory symptoms.
- No history of lung disease.
- Never personally smoked (defined as less 100 cigarettes in their lifetime). -Secondhand smoke exposure is not an exclusion criterion.
Who cannot join
- Blood oxygen saturation of less than 92% as measured by pulse oximetry on the day of imaging.
- FEV1 percent predicted less than 80%.
- Pregnancy or lactation.
- Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded.
- Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches.
- History of congenital cardiac disease, chronic renal failure, or cirrhosis.
Show all 9Show fewer
- Inability to understand simple instructions or to hold still for approximately 10 seconds.
- History of respiratory infection within 2 weeks prior to the MR scan
- History of MI, stroke and/or poorly controlled hypertension.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Roselove Asare, RT, 434-243-6074, rnn3b@virginia.edu
About this study
Official title: Assessing Deformable Image Registration in the Lung Using Hyperpolarized-gas
Recently, the investigators have demonstrated a novel hyperpolarized helium tagging Magnetic Resonance Image (MRI) technique that is capable of directly, in vivo, and non-invasively measuring physiological lung deformation on a regional basis. This unique imaging technique holds great promise for assessing, validating, and improving the use of Deformable image Registration (DIR) algorithms in the lung. Our long term aim is to apply hyperpolarized gas tagging MRI to study lung biomechanics, develop more physiologically sound DIR algorithms for the lungs, and eventually improve radiotherapy of lung cancer. The overall aim of this application is to optimize the hyperpolarized helium tagging MRI technology and establish its usefulness for DIR assessment.
Our first objective is to develop and optimize a methodology based on 3 Dimensional (3D) hyperpolarized helium tagging MRI of healthy subjects, for directly measuring lung deformation between inhalation and exhalation. Our second objective is to develop physiologically sound digital thorax phantoms based on helium-3 tagging MRI of healthy subjects and demonstrate their use for DIR assessment in the lung. These phantoms will be used to evaluate a range different DIR algorithms, by comparing the errors between the DIR-derived deformation vector fields and the ground truth represented in the digital phantom. Successful completion of these aims will yield a novel methodology for DIR assessment in the lung for radiotherapy.
Read the detailed description
The purpose of this study is to develop new ways to make medical images of the lungs and liver of adults using a technique called four-dimensional magnetic resonance imaging (4D-MRI). This technique produces three-dimensional movies of the inside of the chest and abdomen while the patient is breathing. (The fourth dimension is time!)
This new way of medical imaging is being developed to help cancer patients undergoing radiation therapy. Radiation therapy is used to treat cancerous tumors. For radiation therapy to be effective, the precise size, shape, and location of the tumor within the body must be known. A particular difficulty for radiation treatment of lung and liver cancer is that the tumor moves during treatment because the patient is breathing. Therefore, tumor motion must also be incorporated into the treatment plan. This study aims to improve radiation treatment planning through better targeting and dose estimation based on 4D-MRI. Before this new imaging method can be used for radiation treatment planning, it must be tested in living, breathing volunteers.
You are being asked to take part in a research study because you are a cancer patient or a healthy volunteer. You do not have to take part in this study. You should only agree to take part in this study after reading this consent form and discussing it with the study team. You may also discuss this with your family, friends, health care providers or others before you make a decision.
Though you may not be directly helped by being in this study, the information gained by doing this study may help others in the future. You might not want to take part in this study because of the temporary risk of discomfort during the time the subject is asked to lie still in the confined space of the MRI scanner. This discomfort may include claustrophobia (fear of being in a small space), feelings of warmth, muscle twitching due to excited nerves, and exposure to loud thumping noises produced by the MR scanner. If you are pregnant or think you may be pregnant, if would not be safe for you to be in this study.
- Conditions
- Healthy Volunteers
- Being tested
- Hyperpolarized He3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized He3Drug
Also called Helium study
Hyperpolarized Helium can be used as a Contrast Agent for Lung Images using MRI.
| Study group | Role | What they receive |
|---|---|---|
| MRI of lung motion during breathing | Experimental | * A medical history will be obtained defining any present and past history of respiratory illnesses, medications, and hospitalizations and the ability to have MR imaging.
* A urine pregnancy test will be done for women of childbearing potential, who report the possibility that they might be pregnant.
* Before and after MR imaging, a physical exam, spirometry, and a baseline %PO2 will be performed.
* During the MR imaging procedure, the subject's heart rate and blood oxygen saturation will be monitored using an MR compatible pulse oximeter.
* Once positioned in the MR scanner, conventional proton images of the thorax will be obtained to define the lung boundaries for subsequent image alignment. -Free breathing conventional MR imaging will be performed.
* Hyperpolarized helium 3 imaging will be performed at breath hold. Receives: Drug: Hyperpolarized He3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1
The difference between the deformation vector field derived from a given DIR algorithm (dDVF) and the known deformation vector field of the digital phantom (pDVF).
Measured: At time of MRI
Secondary outcomes (2)
Aim 2
The Relationship between the DVF errors and motion amplitude.
Measured: At time of MRI
Aim 3
The relationship between the DVF and lung feature richness
Measured: At time of MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study start1 Jul 2016
- Primary completion15 Dec 2019
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Y. Michael Shim, MD, University of Virginia
- Investigators
- Yun M Shim, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995590
- Sponsor's protocol ID
- 19112
- Status last verified
- Nov 2020
- First submitted
- 13 Dec 2016
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Deformable Image Registration in the Lung Using Hyperpolarized-gas
- ClinicalTrials.gov ID
- NCT02995590
- Acronym / sponsor ID
- 19112
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recently, the investigators have demonstrated a novel hyperpolarized helium tagging Magnetic Resonance Image (MRI) technique that is capable of directly, in vivo, and non-invasively measuring physiological lung deformation on a regional basis. This unique imaging technique holds great promise for assessing, validating, and improving the use of Deformable image Registration (DIR) algorithms in the lung. Our long term aim is to apply hyperpolarized gas tagging MRI to study lung biomechanics, develop more physiologically sound DIR algorithms for the lungs, and eventually improve radiotherapy of lung cancer. The overall aim of this application is to optimize the hyperpolarized helium tagging MRI technology and establish its usefulness for DIR assessment.
Our first objective is to develop and optimize a methodology based on 3 Dimensional (3D) hyperpolarized helium tagging MRI of healthy subjects, for directly measuring lung deformation between inhalation and exhalation. Our second objective is to develop physiologically sound digital thorax phantoms based on helium-3 tagging MRI of healthy subjects and demonstrate their use for DIR assessment in the lung. These phantoms will be used to evaluate a range different DIR algorithms, by comparing the errors between the DIR-derived deformation vector fields and the ground truth represented in the digital phantom. Successful completion of these aims will yield a novel methodology for DIR assessment in the lung for radiotherapy.
Detailed description
The purpose of this study is to develop new ways to make medical images of the lungs and liver of adults using a technique called four-dimensional magnetic resonance imaging (4D-MRI). This technique produces three-dimensional movies of the inside of the chest and abdomen while the patient is breathing. (The fourth dimension is time!)
This new way of medical imaging is being developed to help cancer patients undergoing radiation therapy. Radiation therapy is used to treat cancerous tumors. For radiation therapy to be effective, the precise size, shape, and location of the tumor within the body must be known. A particular difficulty for radiation treatment of lung and liver cancer is that the tumor moves during treatment because the patient is breathing. Therefore, tumor motion must also be incorporated into the treatment plan. This study aims to improve radiation treatment planning through better targeting and dose estimation based on 4D-MRI. Before this new imaging method can be used for radiation treatment planning, it must be tested in living, breathing volunteers.
You are being asked to take part in a research study because you are a cancer patient or a healthy volunteer. You do not have to take part in this study. You should only agree to take part in this study after reading this consent form and discussing it with the study team. You may also discuss this with your family, friends, health care providers or others before you make a decision.
Though you may not be directly helped by being in this study, the information gained by doing this study may help others in the future. You might not want to take part in this study because of the temporary risk of discomfort during the time the subject is asked to lie still in the confined space of the MRI scanner. This discomfort may include claustrophobia (fear of being in a small space), feelings of warmth, muscle twitching due to excited nerves, and exposure to loud thumping noises produced by the MR scanner. If you are pregnant or think you may be pregnant, if would not be safe for you to be in this study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI of lung motion during breathing | Experimental | Drug: Hyperpolarized He3* A medical history will be obtained defining any present and past history of respiratory illnesses, medications, and hospitalizations and the ability to have MR imaging. * A urine pregnancy test will be done for women of childbearing potential, who report the possibility that they might be pregnant. * Before and after MR imaging, a physical exam, spirometry, and a baseline %PO2 will be performed. * During the MR imaging procedure, the subject's heart rate and blood oxygen saturation will be monitored using an MR compatible pulse oximeter. * Once positioned in the MR scanner, conventional proton images of the thorax will be obtained to define the lung boundaries for subsequent image alignment. -Free breathing conventional MR imaging will be performed. * Hyperpolarized helium 3 imaging will be performed at breath hold. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All subjects must be willing to participate and undergo the procedure, and be manageable as out-patients.
- Normal Subjects: Currently feeling well without respiratory symptoms.
- No history of lung disease.
- Never personally smoked (defined as less 100 cigarettes in their lifetime). -Secondhand smoke exposure is not an exclusion criterion.
Key exclusion criteria (9 listed)
- Blood oxygen saturation of less than 92% as measured by pulse oximetry on the day of imaging.
- FEV1 percent predicted less than 80%.
- Pregnancy or lactation.
- Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded.
- Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized He3Also: Helium studyHyperpolarized Helium can be used as a Contrast Agent for Lung Images using MRI. | Drug | MRI of lung motion during breathing |
Primary outcome
Aim 1
Time frame: At time of MRI
The difference between the deformation vector field derived from a given DIR algorithm (dDVF) and the known deformation vector field of the digital phantom (pDVF).
2 secondary outcomes
Aim 2
Time frame: At time of MRI
Aim 3
Time frame: At time of MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun M Shim, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hyperpolarized He3 in people with Healthy Volunteers, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roselove Asare, BSRT (434-243-6074, rnn3b@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1 (time frame: At time of MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020; AzTrials last refreshed its copy on 3 Nov 2026.