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

• ClinicalTrials.gov Identifier: NCT02081092
• Recruitment Status: Completed
• First Posted: March 7, 2014
• Last Update Posted: November 1, 2018
• Sponsor: Children's Hospital Medical Center, Cincinnati
• 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
• 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

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

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
• Current Responsible Party: Children's Hospital Medical Center, Cincinnati
• Original Responsible Party: Same as current
• Current Study Sponsor: Children's Hospital Medical Center, Cincinnati
• Original Study Sponsor: Same as current
• 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