Advanced Immunoclinical Phenotyping of Rejection in Lung Transplant

NCT03697395 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 20987Ithriv
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic allograft rejection of the transplanted lung (CLAD) is a major health issue in patients after lung transplant. This study is a registry-forming study with concurrent tissue banking from surveillance bronchoscopy in addition to extra tissue sampling of blood and urine. Patients will be characterized by usual clinical phenotyping and the latest imaging methods so that diseased condition underlying CLAD can be better understood.

Conditions

Chronic Rejection of Lung Transplant

Outcome Measures

Primary Outcomes (1)

• Successful collection of all samples as proposed.

  Completion of surveillance bronchoscopy and other tissue collection at planned surveillance (24 months after the date of lung transplant surgery)

  24 months after the date of lung transplant surgery

Interventions

Lung transplant recipient without MRI imaging DIAGNOSTIC_TEST

Patients who received lung transplant and undergoing surveillance follow-up at 1, 3, 6, 12, 24 months after the date of lung transplant, but without consenting to be evaluated by hyperbolized gas MRI. Bronchoscopy sampling will be performed per usual lung transplant team protocol.

Also known as: Routine Lung Transplant Surveillance

Lung transplant recipient with MRI imaging DRUG

Patients who received lung transplant and undergoing surveillance follow-up at 1, 3, 6, 12, 24 months after the date of lung transplant and with consenting to be evaluated by hyperbolized has MRI. Bronchoscopy sampling will be guided by the results of the hyper polarized gas MRI, different from the usual lung transplant team protocol. Administration of hyper polarized gas MRI is under FDA regulation by IND #129769 (PI, Yun Michael Shim, MD)

Also known as: Lung Transplant Surveillance with hyper polarized gas MRI

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who successfully underwent lung transplant at the University of Virginia.
• Followed by medical lung transplant team for post-lung transplant rejection surveillance program at the University of Virginia.
• Subjects with co -morbid illnesses such as neurologic, liver and or kidney or GI tract disease/ dysfunction are not excluded
• Clinically stable to undergo MRI Imaging

You may not qualify if:

• Continuous oxygen use at home if decided to consent for MRI imaging
• Blood oxygen saturation of less than 92%as measured by pulse oximetry on the day of imaging if decided to consent for MRI imaging.
• Forced Expiratory Volume in 1 second (FEV1) percent predicted less than 25% if decided to consent for MRI imaging.
• Pregnancy or lactation if decided to consent for MRI imaging.
• Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded if decided to consent for MRI imaging.
• Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches if decided to consent for MRI imaging.
• History of congenital cardiac disease, chronic renal failure, or cirrhosis if decided to consent for MRI imaging.
• Inability to understand simple instructions or to hold still for approximately 10 seconds if decided to consent for MRI imaging.
• History of respiratory infection within 2 weeks prior to the MR scan if decided to consent for MRI imaging.
• History of MI, stroke and/or poorly controlled hypertension if decided to consent for MRI imaging.

Sponsors & Collaborators

• University of Virginia: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Study Officials

• Yun M Shim, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Medical Imaging

Model Details: Part 1-blood and bronch samples will be collected from subjects already undergoing procedures Part 2-blood, bronch samples and MRI will be performed on subject

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 5, 2018
• Study Start: April 1, 2019
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2038
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)