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Clinical Trials/NCT02852473
NCT02852473
Completed
Early Phase 1

Impact of Continuous Positive Airway Pressure on Breathing Motion Amplitude

Mayo Clinic1 site in 1 country10 target enrollmentJuly 2016
ConditionsCancer

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Cancer
Sponsor
Mayo Clinic
Enrollment
10
Locations
1
Primary Endpoint
Change in Breathing Motion Characteristics at High CPAP Setting
Status
Completed
Last Updated
9 years ago

Overview

Brief 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. 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).

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
September 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Erik J. Tryggestad, Ph.D.

Associate Professor of Medical Physics

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Healthy adult female and males
  • Subject meets routine MRI safety criteria

Exclusion Criteria

  • Known history of chronic obstructive pulmonary disease (COPD), asthma, or other chronic pulmonary illness
  • Any safety risk identified via MRI safety screening

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Change in Breathing Motion Characteristics at Lower CPAP Setting(Approximately 45 minutes into visit.)

Study Sites (1)

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