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

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ClinicalTrials.gov Identifier: NCT02081092
Recruitment Status : Completed
First Posted : March 7, 2014
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified 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