NCT02081092

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2018

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

4.9 years

First QC Date

February 12, 2014

Last Update Submit

October 30, 2018

Conditions

Pulmonary Alveolar Proteinosis

Keywords

PAPPulmonary Alveolar ProteinosisPulmonaryPatients

Outcome Measures

Primary Outcomes (1)

  • Comparing MRI's images pre and post whole lung lavage

    24 hours before lung lavage and 24-48 hours after lung lavage

Study Arms (1)

Pulmonary Alveolar Proteinosis (PAP)

Patients diagnosis with Pulmonary Alveolar Proteinosis.

Eligibility Criteria

Age8 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Pulmonary Alveolar Proteinosis

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Pulmonary Alveolar Proteinosis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Jason Woods, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2014

First Posted

March 7, 2014

Study Start

December 1, 2013

Primary Completion

October 29, 2018

Study Completion

October 29, 2018

Last Updated

November 1, 2018

Record last verified: 2018-10

Locations

US(1)