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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02081092
Recruitment Status : Recruiting
First Posted : March 7, 2014
Last Update Posted : January 29, 2018
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease
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
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation and Treatment Planning of Patients With PAP Using Thrive Ultra Short Echo Time MRI and CT
Study Start Date : December 2013
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Pulmonary Alveolar Proteinosis (PAP)
Patients diagnosis with Pulmonary Alveolar Proteinosis.

Primary Outcome Measures :
  1. Comparing MRI's images pre and post whole lung lavage [ Time Frame: 24 hours before lung lavage and 24-48 hours after lung lavage ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Pulmonary Alveolar Proteinosis

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02081092

United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Erin Watters, BA    513-803-7024   
Principal Investigator: Jason Woods, Ph.D.         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Principal Investigator: Jason Woods, MD Children's Hospital Medical Center, Cincinnati

Responsible Party: Children's Hospital Medical Center, Cincinnati Identifier: NCT02081092     History of Changes
Other Study ID Numbers: 2013-7051
First Posted: March 7, 2014    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Pulmonary Alveolar Proteinosis

Additional relevant MeSH terms:
Pulmonary Alveolar Proteinosis
Lung Diseases
Respiratory Tract Diseases