Advanced Immunoclinical Phenotyping of Rejection in Lung Transplant

• Sponsor: University of Virginia (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03697395
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 1,200
• Location: 1
• Anticipated Duration (Months): 237
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Rejection of Lung Transplant	Diagnostic Test: Lung transplant recipient without MRI imaging; Drug: Lung transplant recipient with MRI imaging

Detailed Description

Chronic allograft rejection of the transplanted lung (CLAD) is a major health issue that lead to almost 50% mortality within 5 years from the time of lung transplant. In the past CLAD was exclusively occurring in small airways causing a condition called "Bronchiolitis Obliteran Syndrome" (BOS). However, recently many have observed restrictive changes in lung physiology with or without parenchymal abnormalities. This new CLAD is called RAS or RCLAD. What is also concerning is that RAS is thought to be associated with disproportionally high morbidity and mortality. This clinical trial intends to create a registry of patients who completed lung transplant and who are undergoing routine surveillance bronchoscopy. A subgroup of patients will be characterized by hyper polarized gas magnetic resonance image to enhance detection of CLAD, and to be correlated between the MRI imaging results and clinical/biochemical results. This study is anticipated to advance our understanding of CLAD which is currently inevitably fatal outcome among patients after lung transplant.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1200 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Advanced Immunoclinical Phenotyping of Rejection in Lung Transplant
• Actual Study Start Date: Apr 1, 2019
• Anticipated Primary Completion Date: Dec 31, 2028
• Anticipated Study Completion Date: Dec 31, 2038

Outcome Measures

Primary Outcome Measures

1. Successful collection of all samples as proposed. [24 months after the date of lung transplant surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 83 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. All patients who successfully underwent lung transplant at the University of Virginia.

2. Followed by medical lung transplant team for post-lung transplant rejection surveillance program at the University of Virginia.

3. Subjects with co -morbid illnesses such as neurologic, liver and or kidney or GI tract disease/ dysfunction are not excluded

4. Clinically stable to undergo MRI Imaging

Exclusion Criteria:

1. Continuous oxygen use at home if decided to consent for MRI imaging

2. Blood oxygen saturation of less than 92%as measured by pulse oximetry on the day of imaging if decided to consent for MRI imaging.

3. Forced Expiratory Volume in 1 second (FEV1) percent predicted less than 25% if decided to consent for MRI imaging.

4. Pregnancy or lactation if decided to consent for MRI imaging.

5. 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.

6. 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.

7. History of congenital cardiac disease, chronic renal failure, or cirrhosis if decided to consent for MRI imaging.

8. Inability to understand simple instructions or to hold still for approximately 10 seconds if decided to consent for MRI imaging.

9. History of respiratory infection within 2 weeks prior to the MR scan if decided to consent for MRI imaging.

10. History of MI, stroke and/or poorly controlled hypertension if decided to consent for MRI imaging.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia Health System	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

• University of Virginia
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Yun M Shim, MD, University of Virginia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Y. Michael Shim, MD, Associate Professor of Medicine and Medical Imaging, University of Virginia
• ClinicalTrials.gov Identifier: NCT03697395
• Other Study ID Numbers: 20987; Ithriv
• First Posted: Oct 5, 2018
• Last Update Posted: Mar 8, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Mar 8, 2022