Imaging and Understanding BOS in Lung Transplantation | NCT02316392

Studies
Imaging and Understanding BOS in Lung Transplantation

NCT02316392

Sponsor

Children's Hospital Medical Center, Cincinnati

Status

Completed

Last Update Posted

Aug 25, 2023Actual

Enrollment

6Actual

Phase

Not provided

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

Hyperpolarized Helium-3 MRI

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Feb 2017Actual

Completion Date

Feb 2017Actual

First Submitted Date

Dec 10, 2014

First Submission Date that Met QC Criteria

Dec 11, 2014

First Posted Date

Dec 12, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2023

Last Update Posted Date

Aug 25, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This study is a prospective, non-randomized, longitudinal, observational study that will recruit about 5 lung transplant patients per year for 3 years. We will follow these patients at 6 months and 1 year with Hyperpolarized Helium-3 Magnetic Resonance Imaging and image guided bronchial biopsies to detect early BOS and to better understand BO disease progression. The biopsies will provide future research for rapid determination of cellular and molecular mechanisms that lead to BOS and to facilitate identification and validation of translatable pharmaceutical targets.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Hyperpolarized Helium-3 MRI	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analysis of MRI imaging to detect BOS compared to biopsy	Analysis of MRI imaging to detect BOS compared to biopsy	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
Inability to perform 10 second breath hold for 3He MRI scan
Bleeding disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Subjects who have had or are scheduled for lung transplant

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jason Woods, PhD.	Cincinnati Children's	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Medical Center		Cincinnati	Ohio	45229	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

There is no plan to share IPD with other researchers at this time. If this plan changes, no identifiable information will be shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000092122	Bronchiolitis Obliterans Syndrome

Ancestor Terms

ID	Term
D000092124	Organizing Pneumonia
D001989	Bronchiolitis Obliterans
D001988	Bronchiolitis
D001991	Bronchitis

Browse Leaves

Not provided

Browse Branches

Not provided