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

Lung Transplant Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06309628
• Other study ID #: PGX-006
• Status: Enrolling by invitation
• Start date: September 21, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Paragonix Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplant Rejection

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Paragonix Technologies	Picomole Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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