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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Alveolar Proteinosis

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
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 75 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Pulmonary Alveolar Proteinosis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pulmonary Alveolar Proteinosis (PAP); Patients diagnosis with Pulmonary Alveolar Proteinosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparing MRI's images pre and post whole lung lavage	24 hours before lung lavage and 24-48 hours after lung lavage

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Jason Woods, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): October 29, 2018
• Study Completion (ACTUAL): October 29, 2018

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: March 6, 2014
• First Posted (ESTIMATE): March 7, 2014

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2018
• Last Update Submitted That Met QC Criteria: October 30, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Patients; Pulmonary; Pulmonary Alveolar Proteinosis; PAP
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Alveolar Proteinosis
• Other Study ID Numbers: 2013-7051