PET Assessment of Acute Lung Transplant Rejection

NCT02204202 | Terminated

• 2 other identifiers: 1R01HL121218-01-201102155R01HL121218
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Disease

Keywords

acute lung transplant rejection; neutrophilic lung inflammation; positron emission tomography imaging; [18F] fluorodeoxyglucose; [18F] ISO-1

Outcome Measures

Primary Outcomes (2)

• Ki, the influx constant that describes the rate of [18F]FDG uptake, in the whole lung

  This outcome measure is assessed from the [18F]FDG scan performed on Day 1.

• Logan plot analysis determined distribution volume ratio (DVR) of [18F] ISO-1 uptake

  This outcome measure is assessed from the [18F]ISO-1 PET scan performed on Day 2.

Secondary Outcomes (1)

• Progesterone receptor membrane component 1 (PGRMC1) staining of biopsy tissues and bronchoalveolar lavage cells

  Assessed after the baseline clinical bronchoscopy procedure is performed 3 days prior to FDG PET/CT scan

Study Arms (2)

Grade A0

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

Drug: [18F]FDG; Drug: [18F]ISO-1

Grades A2-3

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

Drug: [18F]FDG; Drug: [18F]ISO-1

Interventions

[18F]FDG DRUG

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

Also known as: fluorodeoxyglucose

Grade A0; Grades A2-3

[18F]ISO-1 DRUG

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

Also known as: F-18 labeled proliferation tracer targeting PGRMC1

Grade A0; Grades A2-3

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient within 7 months of double-lung transplantation and who is scheduled for bronchoscopy with biopsy will be eligible. Patients will be identified via the bronchoscopy schedule through the Lung Transplant Center at Barnes-Jewish Hospital / Washington University School of Medicine and approached for potential participation prior to their scheduled bronchoscopy. PET/CT imaging with \[18F\]FDG will be performed, if consented, no more than 3 days after results from the biopsy are reported. \[18F\]ISO-1 PET/CT imaging will be performed the day after \[18F\]FDG PET and can be performed after treatment for acute rejection has been initiated. We intend to image 30 lung transplant recipients with no evidence of rejection (grade A0) and 30 recipients with mild to moderate (grades A2-3) rejection.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Washington University School of Medicine / Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

cells from bronchoalveolar lavage specimen; tissues from biopsy specimens

MeSH Terms

Conditions

Lung Diseases

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Delphine L Chen, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 30, 2014
• Study Start: February 1, 2014
• Primary Completion: February 4, 2017
• Study Completion: February 4, 2017
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

US (1)