NCT02316392

Brief Summary

This study is a prospective, non-randomized, longitudinal, observational study that will recruit about 5 lung transplant patients per year for 3 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2014

Typical duration 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, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

2.2 years

First QC Date

December 10, 2014

Last Update Submit

August 23, 2023

Conditions

Bronchiolitis Obliterans Syndrome

Keywords

HeliumMRILung transplantation

Outcome Measures

Primary Outcomes (1)

  • Analysis of MRI imaging to detect BOS compared to biopsy

    Analysis of MRI imaging to detect BOS compared to biopsy

    3 years

Study Arms (1)

Post transplant subjects

Hyperpolarized Helium-3 MRI. Subjects who have had or are scheduled to have a lung transplant

Drug: Hyperpolarized Helium-3 MRI

Interventions

Hyperpolarized Helium-3 MRIDRUG

Subjects will inhale Hyperpolarized Helium-3 gas during the MRI. This gas enhances images and the data collected will be used to determine if it can be used to detect BOS earlier than current standard of care.

Also known as: Hp-He3 MRI
Post transplant subjects

Eligibility Criteria

Age1 Year - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects who have had or are scheduled for lung transplant

You may qualify if:

  • Lung Transplantation within the last 10 years or being assessed for possible lung transplantation.
  • Male or female
  • to 25 years of age.

You may not qualify if:

  • Inability to perform 10 second breath hold for 3He MRI scan
  • Bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biopsies of transplanted and explanted lung tissue

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Jason Woods, PhD.

    Cincinnati Children's

    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

December 10, 2014

First Posted

December 12, 2014

Study Start

December 1, 2014

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

August 25, 2023

Record last verified: 2023-08

Locations

US(1)