CancerEarly Phase 1NCT02852473
Impact of Continuous Positive Airway Pressure on Breathing Motion Amplitude
A Early Phase 1 study testing Continuous Positive Airway Pressure in people with Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
This study involves a breathing motion assessment in healthy subjects before and after continuous positive airway pressure (CPAP) administration using MRI images. The hypothesis for this study is that CPAP administration will significantly reduce breathing motion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Continuous Positive Airway Pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Sep 2016
- Phase
- Early 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult female and males
- Subject meets routine MRI safety criteria
Who cannot join
- Age <18
- Known history of chronic obstructive pulmonary disease (COPD), asthma, or other chronic pulmonary illness
- Pregnancy
- Any safety risk identified via MRI safety screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
This study involves a breathing motion assessment in healthy subjects before and after continuous positive airway pressure (CPAP) administration using MRI images.
The hypothesis for this study is that CPAP administration will significantly reduce breathing motion. This may help cancer patients who are undergoing proton radiotherapy, so they possibly will not have to hold their breath during the procedure.
Read the detailed description
Minimally invasive techniques for tumor motion reduction that involve free-breathing patients have significant relevance in the context of radiation therapy, in particular proton radiotherapy. Tumor motion reduction has favorable implications for reduction of radiation doses to adjacent healthy organs, radiation plan robustness (accuracy/quality) and for treatment efficiency (reduction of treatment times). Using non-ionizing MRI with volunteers, the investigators will determine the extent to which continuous positive airway pressure (CPAP) reduces breathing motion (diaphragmatic excursion). The researchers will also investigate the parameter space associated with breathing motion reduction versus the amount of pressure applied, as well as timing of initiation of CPAP in relation to the imaging time point (to address whether an initial transient breathing state exists).
- Conditions
- Cancer
- Being tested
- Continuous Positive Airway Pressure
- Keywords
- Continuous Positive Airway Pressure, Radiotherapy, Proton Therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway PressureOther
CPAP requires subjects to wear a plastic pressurized mask/apparatus, which is connected via a filter and hose to a pump capable of supplying variable pressure (typically on the range of 4-20 cm H2O). The investigators plan to use a full-face mask to prevent subjects from reducing pressure by opening their mouths. If this cannot be tolerated or properly fitted, or is not compatible with the CPAP ventilator, subjects would use a nasal mask only and be asked to keep their mouths closed.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Positive Airway Pressure | Experimental | Continuous Positive Airway Pressure (CPAP) will be administered using FDA-approved equipment. Receives: Other: Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Breathing Motion Characteristics at High CPAP Setting
Breathing motion at baseline and at initial (higher but tolerable) CPAP settings will be characterized using fast multi-slice, multi-phase 2D gradient-echo or spin-echo MRI sequences in the sagittal or coronal imaging planes over a large field of view covering the thoracic and upper-abdominal region. Specifically "4D-MRI" (or time-resolved MRI) will be generated from retrospective sorting of multi-slice 2D MRI. For these analyses, anatomic reference points (e.g., bright vessels) in multiple organ systems will be identified on the images, contoured or segmented; subsequently 3D motion patterns will be extracted for all anatomical references/features. Numerical simulations will be performed to determine hypothetical radiation target volume changes (cm^3) at these anatomic locations assuming spherical tumors with a given set of tumor diameters (cm).
Measured: Data acquisition for this portion of the study will require approximately 30 minutes.
Secondary outcomes (1)
Change in Breathing Motion Characteristics at Lower CPAP Setting
Time permitting, the CPAP setting will be reduced to approximately half of the nominal/tolerable/high CPAP setting. Using the same MRI sequences and retrospective sorting technique, 4D-MRI will be generated for this lower CPAP setting. Analogous motion characterization analyses (to outcome measure 1) will be carried out for the lower CPAP setting (relative to baseline 4D-MRI).
Measured: Approximately 45 minutes into visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik J. Tryggestad, Ph.D., Mayo Clinic
- Investigators
- Erik J Tryggestad, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852473
- Sponsor's protocol ID
- 16-001685
- Status last verified
- Oct 2016
- First submitted
- 3 Jun 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Continuous Positive Airway Pressure on Breathing Motion Amplitude
- ClinicalTrials.gov ID
- NCT02852473
- Acronym / sponsor ID
- 16-001685
- Conditions
- Cancer
- Keywords
- Continuous Positive Airway Pressure, Radiotherapy, Proton Therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Aug 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.
This study involves a breathing motion assessment in healthy subjects before and after continuous positive airway pressure (CPAP) administration using MRI images.
The hypothesis for this study is that CPAP administration will significantly reduce breathing motion. This may help cancer patients who are undergoing proton radiotherapy, so they possibly will not have to hold their breath during the procedure.
Detailed description
Minimally invasive techniques for tumor motion reduction that involve free-breathing patients have significant relevance in the context of radiation therapy, in particular proton radiotherapy. Tumor motion reduction has favorable implications for reduction of radiation doses to adjacent healthy organs, radiation plan robustness (accuracy/quality) and for treatment efficiency (reduction of treatment times). Using non-ionizing MRI with volunteers, the investigators will determine the extent to which continuous positive airway pressure (CPAP) reduces breathing motion (diaphragmatic excursion). The researchers will also investigate the parameter space associated with breathing motion reduction versus the amount of pressure applied, as well as timing of initiation of CPAP in relation to the imaging time point (to address whether an initial transient breathing state exists).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Positive Airway Pressure | Experimental | Other: Continuous Positive Airway PressureContinuous Positive Airway Pressure (CPAP) will be administered using FDA-approved equipment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adult female and males
- Subject meets routine MRI safety criteria
Key exclusion criteria (4 listed)
- Age <18
- Known history of chronic obstructive pulmonary disease (COPD), asthma, or other chronic pulmonary illness
- Pregnancy
- Any safety risk identified via MRI safety screening
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 |
|---|---|---|
| Continuous Positive Airway PressureCPAP requires subjects to wear a plastic pressurized mask/apparatus, which is connected via a filter and hose to a pump capable of supplying variable pressure (typically on the range of 4-20 cm H2O). The investigators plan to use a full-face mask to prevent subjects from reducing pressure by opening their mouths. If this cannot be tolerated or properly fitted, or is not compatible with the CPAP ventilator, subjects would use a nasal mask only and be asked to keep their mouths closed. | Other | Continuous Positive Airway Pressure |
Primary outcome
Change in Breathing Motion Characteristics at High CPAP Setting
Time frame: Data acquisition for this portion of the study will require approximately 30 minutes.
Breathing motion at baseline and at initial (higher but tolerable) CPAP settings will be characterized using fast multi-slice, multi-phase 2D gradient-echo or spin-echo MRI sequences in the sagittal or coronal imaging planes over a large field of view covering the thoracic and upper-abdominal region. Specifically "4D-MRI" (or time-resolved MRI) will be generated from retrospective sorting of multi-slice 2D MRI. For these analyses, anatomic reference points (e.g., bright vessels) in multiple organ systems will be identified on the images, contoured or segmented; subsequently 3D motion patterns will be extracted for all anatomical references/features. Numerical simulations will be performed to determine hypothetical radiation target volume changes (cm^3) at these anatomic locations assuming spherical tumors with a given set of tumor diameters (cm).
1 secondary outcome
Change in Breathing Motion Characteristics at Lower CPAP Setting
Time frame: Approximately 45 minutes into visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Erik J Tryggestad, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Continuous Positive Airway Pressure in people with Cancer, run by Mayo Clinic 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 14 Oct 2016. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Breathing Motion Characteristics at High CPAP Setting (time frame: Data acquisition for this portion of the study will require approximately 30 minutes.). 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 14 Oct 2016.