Lung Transplant RejectionNCT06309628
Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection Patients Using Infrared Spectroscopy
An observational study of Lung Transplant Rejection, run by Paragonix Technologies at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant Rejection
- What is being tested?
- Breathe sample
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2023to 9 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients who are receiving a bronchoscopy at least 90 days after a lung transplant.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Transplant Rejection
- Being tested
- Breathe sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathe sampleDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Breathe sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: three to twelve months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start21 Sep 2023
- Primary completion9 May 2025
- Study completion9 May 2025
Why it stopped: Interim determination of missed feasibility goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paragonix Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Breathe BioMedical Inc
- Responsible party
- Sponsor
- Investigators
- Matthew Hartwig, MD, Principal investigator, Duke UniversityMatthew Pipeling, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309628
- Sponsor's protocol ID
- PGX-006
- Status last verified
- May 2025
- First submitted
- 7 Mar 2024
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection
- ClinicalTrials.gov ID
- NCT06309628
- Acronym / sponsor ID
- PGX-006
- Conditions
- Lung Transplant Rejection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Interim determination of missed feasibility goals
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Paragonix TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Breathe BioMedical Inc
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Transplant patients at risk for rejection | – | Diagnostic Test: Breathe samplePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients who are receiving a bronchoscopy at least 90 days after a lung transplant.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathe samplePatients will provide two breathe sample into the Breathe device to see if their VOC patterns can be used to diagnose lung transplant rejection. | Diagnostic test | Lung Transplant patients at risk for rejection |
Primary outcome
Volatile Organic Compound profile
Time frame: three to twelve months post-transplant
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
Results and safety
The study was stopped early (reason given: Interim determination of missed feasibility goals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
Related trials for Lung Transplant Rejection
RecruitingPhase 1
Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies
Lung Transplantation
RecruitingPhase 3
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Lung Transplant Rejection
RecruitingPhase 1
A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation
Antibody Mediated Rejection of Lung Transplant
RecruitingPhase 2
Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
Lung Transplant
RecruitingObservational study
Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes
Lung Transplant; Complications, Lung Transplant; Infection or Inflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Hartwig, MD principal investigator
Duke University
Matthew Pipeling principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant Rejection, run by Paragonix Technologies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Interim determination of missed feasibility goals). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volatile Organic Compound profile (time frame: three to twelve months post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.