Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection Patients Using Infrared Spectroscopy

Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection

This study will sample and analyze volatile organic compounds (VOCs) from participants considered to be at risk for developing rejection following lung transplant by using infrared spectroscopy.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lung Transplant Rejection
• Intervention / Treatment: Diagnostic test: Breathe sample

Detailed Description

The aim of this study is to sample and analyze volatile organic compounds (VOCs) from participants considered to be at risk for developing rejection following lung transplant. By using infrared spectroscopy, the breath sample analysis will help investigators describe and identify patterns of VOCs that are over- or under-represented in patients with post-lung transplant rejection when compared to the breath profiles of those without rejection. It is hypothesized that the profile of volatile chemicals in the breath of patients in the early stages of rejection will differ significantly from those individuals without rejection.

Primary objective

• To analyze the breath-born VOCs in breath profiles of lung transplant patients with rejection in comparison to lung transplant patients without rejection using infrared spectroscopy to determine the presence of lung rejection and to develop mathematical/statistical models of infrared absorption spectrum for identification of rejection.

Secondary objective

• To determine the best method to classify health status based on VOC data of breath samples
• To validate early test results on an additional infrared spectroscopic analyzer in post-lung transplant patients

The study is an unblinded, prospective case-control study. The study cohorts will include: 1) patients with confirmed post-lung transplant rejection via biopsy, and 2) control patients who have undergone lung transplant but are free from rejection as confirmed via biopsy. Breath samples collected from participants will be analyzed to characterize and further identify differences in infrared absorption profiles from each cohort using infrared spectroscopy. The data will be used to validate a previously developed machine learning algorithm.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients who are receiving a bronchoscopy at least 90 days after a lung transplant.

Description

Inclusion Criteria:

• Age 18 and older
• Patient is able to give informed consent
• Lung transplant patient who had both lungs transplanted
• Patient is at least 90 days after their lung transplant
• Patient is able to provide a breath sample

Exclusion Criteria:

• Patient is less than 18 years old
• Patient received multiple organ transplants
• Patient had an organ transplant prior to their lung transplant
• Patients who received a single lung transplant
• Patient less than 90 days or more than 1 year from their lung transplant
• If patient has smoked 4 hours or less before breath sample or consumed alcohol (including mouthwash) 8 hours or less before breath sample

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung Transplant patients at risk for rejection; Patients who have had a lung transplant and are getting a bronchoscopy to test for rejection will provide a breathe sample. Once their rejection results come back after their sample has been collected their breathe samples will be sorted into rejection and non-rejection groups for analysis. All patients will have the same experiences in the study.	Diagnostic test: Breathe sample; Patients will provide two breathe sample into the Breathe device to see if their VOC patterns can be used to diagnose lung transplant rejection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volatile Organic Compound profile	The VOCs in the breath of patients experiencing lung rejection post-transplant per bronchoscopy will be compared to lung transplant patients who are not experiencing rejection	three to twelve months post-transplant

Collaborators and Investigators

• Sponsor: Paragonix Technologies
• Collaborators: Picomole Inc
• Investigators: Principal Investigator: Matthew Hartwig, MD, Duke University; Principal Investigator: Matthew Pipeling, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PGX-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No