Evaluation and Treatment Planning of Patients With PAP Using Thrive Ultra Short Echo Time MRI and CT (PAP)

Tracking Information
First Submitted Date	February 12, 2014
First Posted Date	March 7, 2014
Last Update Posted Date	November 1, 2018
Study Start Date	December 2013
Actual Primary Completion Date	October 29, 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: March 6, 2014)	Comparing MRI's images pre and post whole lung lavage [ Time Frame: 24 hours before lung lavage and 24-48 hours after lung lavage ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT02081092 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Evaluation and Treatment Planning of Patients With PAP Using Thrive Ultra Short Echo Time MRI and CT
Official Title	Evaluation and Treatment Planning of Patients With PAP Using Thrive Ultra Short Echo Time MRI and CT
Brief Summary	The purpose of this study is twofold: to assess routine cat scan (CT) imaging as a biomarker for removal of lipoprotein surfactant via lung lavage (where CT is the gold-standard imaging technique for density quantification), and to utilize a novel UTE MRI protocol to similarly quantify surfactant removal. This study will also serve to generate baseline scanning that may aid in developing analytical tools to evaluate and treat specific lung regions of patients with PAP.
Detailed Description	This study will evaluate x-ray CT as a biomarker for surfactant lavage removal and evaluate an UTE-Thrive MRI protocol at CCHMC as an imaging alternative to CT. Potential subjects who meet study criteria will be identified by the Pulmonary physicians at Cincinnati Children's Hospital Medical Center (CCHMC) and University of Cincinnati (UC) through their clinic patients. The study will include two research MRIs (one pre lavage and the second 24 to 72 hours after the first lung lavage) and if there is a clinical CT performed pre lavage, then one research CT will also be performed with the second research MRI. All image analysis will be quantitative. Whole-lung and regional density will be calculated and evaluated before and after lung lavage, for a quantification of changes in density in the left lung and right lung separately. Since the one lung will serve as control, it will allow precise error estimation (which we expect to be quite small and largely related to differences in lung volume). One purpose of this protocol is to further refine and develop ultra-short echo time (UTE) MRI techniques since Pulmonary Alveolar Proteinosis (PAP) patients may have multiple lavage sessions per year. A subject may be eligible to re-enroll to participate multiple times if the total number of research CTs for all enrollments is one or less for that subject.
Study Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Patients with Pulmonary Alveolar Proteinosis
Condition	Pulmonary Alveolar Proteinosis
Intervention	Not Provided
Study Groups/Cohorts	Pulmonary Alveolar Proteinosis (PAP); Patients diagnosis with Pulmonary Alveolar Proteinosis.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: October 30, 2018)	9
Original Estimated Enrollment; (submitted: March 6, 2014)	15
Actual Study Completion Date	October 29, 2018
Actual Primary Completion Date	October 29, 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: Clinically diagnosed PAP scheduled for lung lavage with double lumen endoscopy.; Children patients ≥ 8 years of age; Adult patients ≤ 75 years of age; Medically stable as per the opinion of Bruce Trapnell, MD or Robert Wood, MD; Patient and or parent consent obtained Exclusion Criteria: Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology; Pregnancy
Sex/Gender	Sexes Eligible for Study: All
Ages	8 Years to 75 Years (Child, Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT02081092
Other Study ID Numbers	2013-7051
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Children's Hospital Medical Center, Cincinnati
Study Sponsor	Children's Hospital Medical Center, Cincinnati
Collaborators	Not Provided
Investigators	Principal Investigator: Jason Woods, MD Children's Hospital Medical Center, Cincinnati
PRS Account	Children's Hospital Medical Center, Cincinnati
Verification Date	October 2018