PET Assessment of Acute Lung Transplant Rejection

NCT ID: NCT02204202

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-02-04

Brief Summary

The purpose of this research study is to gain understanding of the basic responses of the lungs to inflammation and specifically if there may be a better way to detect graft inflammation using non-invasive methods as well as to determine the effectiveness of immunosuppressive treatment regimens in preventing acute rejection in lung transplant recipients.

Detailed Description

Positron emission tomography with fluorodeoxyglucose (FDG-PET) is a potential way we can measure lung inflammation. FDG-PET imaging is a clinically accepted and FDA-approved method that is commonly used in the diagnosis and management of cancer. PET is a machine that detects radiation and generates pictures using a donut shaped scanner similar in appearance to an x-ray "CAT" computerized axial tomography or computed tomography (CT) scan. FDG stands for [18F] (flourine 18) fluorodeoxyglucose, a radiolabeled sugar that is used to identify areas of inflammation with the PET scanner. A CT scan takes a picture of what the lungs and airways look like.

T cells are the primary cause of acute rejection of lung transplants. Because T cells must divide in order to be activated and cause rejection, imaging them while they are dividing is another way that we can determine whether acute rejection is occurring. A new PET tracer called [18F]ISO-1 (18F-labeled σ2-receptor ligand for PET, N-(4-(6,7-dimethoxy-3,-4-dihydroisoquinolin-2(1H)-yl)butyl)-2-(2-18F-fluoroethoxy)-5-methylbenzamide (18F-3c), binds to dividing cells. Therefore, [18F]ISO-1 may help us measure acute rejection more accurately. [18F]ISO-1 is an investigational drug.

Conditions

Lung Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Grade A0

Double-lung transplant recipients with no evidence of rejection who undergo both \[18F\]FDG and \[18F\]ISO-1 PET imaging scans

[18F]FDG

Intervention Type: DRUG

10 millicuries (mCi) of \[18F\]FDG will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition

[18F]ISO-1

Intervention Type: DRUG

8 mCi of \[18F\]ISO-1 will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition

Grades A2-3

Double-lung transplant recipients with mild to moderate rejection who undergo both \[18F\]FDG and \[18F\]ISO-1 PET imaging scans

[18F]FDG

Intervention Type: DRUG

10 millicuries (mCi) of \[18F\]FDG will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition

[18F]ISO-1

Intervention Type: DRUG

8 mCi of \[18F\]ISO-1 will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition

Interventions

[18F]FDG

10 millicuries (mCi) of \[18F\]FDG will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition

Intervention Type: DRUG

[18F]ISO-1

8 mCi of \[18F\]ISO-1 will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition

Intervention Type: DRUG

Other Intervention Names

fluorodeoxyglucose; F-18 labeled proliferation tracer targeting PGRMC1

Eligibility Criteria

Inclusion Criteria

• Double-lung transplant recipient
• Scheduled for bronchoscopy with transbronchial biopsy
• Capable of lying still and supine with arms raised above the head within the PET/CT scanner for ~1.25 hours
• Capable of following instructions for breathing protocol during CT portion of PET/CT
• Able and willing to give informed consent
• BMI < 35
• Already scheduled to undergo bronchoscopy with bronchoalveolar lavage (BAL) for clinical reasons
• Willing to donate a portion of BAL and biopsy specimen for laboratory testing

Exclusion Criteria

• Glucose level > 150 mg/dl at time of [18F]FDG PET scan (however, up to 160 mg/dl, with repeat testing showing level is stable or decreasing, is acceptable)
• Pregnancy (confirmed by qualitative urine human chorionic gonadotropin (hCG) pregnancy test)
• Lactation
• Presence of implanted electronic medical device
• Enrollment in another research study of an investigational drug
• Inability to lie flat with arms raised above the head for 1.5 hours for PET/CT scans or follow breathing protocol instructions for the CT portion of the PET/CT

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Delphine L Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine / Barnes-Jewish Hospital

St Louis, Missouri, United States

Countries

United States

Other Identifiers

R01HL121218

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01HL121218-01-201102155

Identifier Type: -

Identifier Source: org_study_id