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

NCT06309628 | Terminated

• 1 other identifier: PGX-006
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Transplant Rejection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Breathe sample DIAGNOSTIC_TEST

Patients will provide two breathe sample into the Breathe device to see if their VOC patterns can be used to diagnose lung transplant rejection.

Lung Transplant patients at risk for rejection

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paragonix Technologies: lead
• Breathe BioMedical Inc: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A sample of the subject's breath, exhaled into a tube.

Study Officials

• Matthew Hartwig, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Matthew Pipeling

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 13, 2024
• Study Start: September 21, 2023
• Primary Completion: May 9, 2025
• Study Completion: May 9, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

US (1)