Lung CancerPOPPYNCT06494254
Post-Operative Prediction of PulmonarY Function
An observational study of Lung Cancer, run by University of Sydney at 1 site in Australia.
Trial summary
Prediction of postoperative lung function is currently based on anatomical segment counting (ASC), which incorporates pulmonary function test (PFT) results. Standard PFTs such as spirometry can only measure pulmonary capacity as an average over the entire lung and do not take regional function differences into… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Jun 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: A pilot study is not a hypothesis testing study. Although this design has patients being their own control, the small sample size of 15 patients is unlikely to capture the full diversity of the population. Therefore, the statistical tests are for hypothesis generation and not definitive.
Who may be able to join
- Aged 18 years or older.
- ECOG performance status 0-2.
- Lung cancer surgical candidates.
- Undergo SPECT V/Q scans within 8 weeks of registration.
- Undergo BHCT scans within 8 weeks of registration.
- Pulmonary function tests within 8 weeks of registration.
- Willingness to give written informed consent.
- Willingness and ability to comply with the study procedures and visit requirements.
Who cannot join
- Interstitial lung disease.
- Pregnant women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065
Shona Silvester, 0413681368, shona.silvester@sydney.edu.au
About this study
Official title: Post-Operative Prediction of PulmonarY Function A Pilot Study to Assess the Benefit of Incorporating Regional Ventilation Information in the Prediction of Post-operative Lung Function for Lung Cancer Surgery
Prediction of postoperative lung function is currently based on anatomical segment counting (ASC), which incorporates pulmonary function test (PFT) results. Standard PFTs such as spirometry can only measure pulmonary capacity as an average over the entire lung and do not take regional function differences into account. Nuclear medicine is recommended where regional functional imaging is required to inform surgical decisions. However, nuclear medicine scans are expensive, time consuming and not available in all institutions. CT-ventilation imaging is a cheaper and more accessible alternative to nuclear medicine for informing lung cancer patient treatment choices.
The primary aim is to quantify the difference between predicted postoperative values of pulmonary function metrics derived from CT ventilation imaging and standard anatomical segment counting method.
Read the detailed description
Lung cancer is the leading cause of cancer mortality worldwide with non-small cell lung cancers (NSCLC) accounting for approximately 85% of all lung cancers diagnosed. Surgical resection is the primary treatment for stage I and II non-small cell lung cancer (NSCLC) in patients with good or low surgical risk. However, in high-risk or medically inoperable patients, radiation therapy may be recommended for primary treatment. Risk stratification of lung cancer patients for surgery is an important preoperative physiological assessment, taking into account cardiovascular health, pulmonary function, comorbidities and predicted postoperative lung function.
Patients with predicted postoperative forced expiratory volume in 1 second (ppoFEV1) or predicted postoperative diffusing capacity for carbon monoxide (ppoDLCO) of less than 40% of predicted normal values have significantly increased risk of perioperative complications or death. Due to the possibility of postoperative respiratory failure, these patients and are often excluded from surgical resection.
Prediction of postoperative lung function is currently based on anatomical segment counting (ASC), which incorporates pulmonary function test (PFT) results. Standard PFTs such as spirometry can only measure pulmonary capacity as an average over the entire lung and do not take regional function differences into account. The predictive validity of the ASC method is less accurate for patients with physiologically compromised lungs such as those with chronic obstructive pulmonary disease (COPD), which is highly prevalent in the NSCLC population. Moreover, as pulmonary function deficit is most likely to be concentrated in the region of the tumour, the ASC method may underestimate post-operative lung function, leading to some patients being wrongly ruled out from receiving surgical treatment.
Nuclear medicine is recommended where regional functional imaging is required to inform surgical decisions. However, nuclear medicine scans are expensive, time consuming and not available in all institutions. CT-ventilation imaging is a cheaper and more accessible alternative to nuclear medicine for informing lung cancer patient treatment choices.
Introduction to CT ventilation imaging CT Ventilation imaging is a novel software-based solution for generating lung function (ventilation) maps from respiratory correlated CT scans, such as breath hold CT (BHCT), where the patient holds their breath for the duration of the scan.
The key steps in CT ventilation imaging are:
- Acquire CT images of the lung at exhale and inhale states, using breath hold CT (BHCT). In BHCT, static end-inspiration and end-expiration images of the lung are acquired as the patient holds their breath for around 10 seconds.
- Deformable image registration is used to determine a spatial mapping (deformation map) between the different CT images (from peak inhale to peak exhale).
- Application of a ventilation metric to quantify high and low functioning lungs which involve quantitative analysis based on the information from the deformable image registration.
The resulting ventilation image is superimposed directly onto the anatomic image, providing an added dimension of functional information which is easy to understand and can be of direct benefit in surgery interventions.
Use of CT Ventilation imaging in assessing lung function for surgery CT Ventilation imaging has been proposed to improve predicted estimates of post-operative lung function by providing regional information on lung function. A preliminary study carried out at Royal North Shore Hospital testing the feasibility of CT Ventilation imaging as a decision tool for marginally resectable patients concluded that lung function derived by CT ventilation imaging correlates strongly with the gold standard PET ventilation on a lobar level.
CT perfusion imaging Lung perfusion imaging is commonly performed together with SPECT ventilation imaging by injecting 99mTc labelled macroaggregated albumen. Following the success of CT based ventilation imaging technique, a new emerging research area is focusing on the development of novel algorithms to assess the blood flow information from the acquired CT images. These modalities will enable us to derive both ventilation and perfusion information.
- Conditions
- Lung Cancer
- Keywords
- ventilation imaging, CT ventilation imaging, lung cancer, lung imaging
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of CT ventilation imaging compared to ASC in predicting postoperative values of the pulmonary function metric FEV1
The accuracy of CT ventilation imaging compared to ASC in predicting postoperative values of the pulmonary function metric FEV1 will be assessed via a comparison with actual postoperative values measured from PFTs. CT ventilation images will be used to produce regionally-informed ppoFEV1 by proportionally reducing the pre-surgery FEV1 by the proportion of ventilation lost by removal of the surgical target section of lung. As this is an investigative study, it is not powered for a statistical analysis. Bland-Altman analysis will be used to quantify the ability of ASC and CT ventilation to predict ppoFEV1
Measured: 1 week
Secondary outcomes (3)
The accuracy of CT ventilation imaging in predicting ppoFEV1
The accuracy of CT ventilation imaging in predicting ppoFEV1will be compared to that of SPECT ventilation imaging. Bland-Altman analysis will be used to quantify the ability of SPECT and CT ventilation to predict ppoFEV1
Measured: 1 week
The regional pattern of ventilation from CT ventilation imaging will be compared to ventilation from SPECT using Spearman correlation.
The average Spearman correlation across all patients will be > 0.6.
Measured: 1 week
The regional pattern of perfusion from CT perfusion imaging will be compared to perfusion from SPECT using Spearman correlation.
The average Spearman correlation across all patients will be > 0.6.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start25 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Royal North Shore Hospital
- Responsible party
- Sponsor
- Investigators
- Dasantha Jayamanne, Dr, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494254
- Sponsor's protocol ID
- IX-2023-OV-POPPY
- Acronym
- POPPY
- Status last verified
- May 2026
- First submitted
- 2 Jul 2024
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified patient images and demographic data will be shared to a public repository for future research.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Prediction of PulmonarY Function A Pilot Study to Assess the Benefit of Incorporating Regional Ventilation Information in the Prediction of Post-operative Lung Function for Lung Cancer Surgery
- ClinicalTrials.gov ID
- NCT06494254
- Acronym / sponsor ID
- POPPY / IX-2023-OV-POPPY
- Conditions
- Lung Cancer
- Keywords
- ventilation imaging, CT ventilation imaging, lung cancer, lung imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- Royal North Shore Hospital
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Jul 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.
Prediction of postoperative lung function is currently based on anatomical segment counting (ASC), which incorporates pulmonary function test (PFT) results. Standard PFTs such as spirometry can only measure pulmonary capacity as an average over the entire lung and do not take regional function differences into account. Nuclear medicine is recommended where regional functional imaging is required to inform surgical decisions. However, nuclear medicine scans are expensive, time consuming and not available in all institutions. CT-ventilation imaging is a cheaper and more accessible alternative to nuclear medicine for informing lung cancer patient treatment choices.
The primary aim is to quantify the difference between predicted postoperative values of pulmonary function metrics derived from CT ventilation imaging and standard anatomical segment counting method.
Detailed description
Lung cancer is the leading cause of cancer mortality worldwide with non-small cell lung cancers (NSCLC) accounting for approximately 85% of all lung cancers diagnosed. Surgical resection is the primary treatment for stage I and II non-small cell lung cancer (NSCLC) in patients with good or low surgical risk. However, in high-risk or medically inoperable patients, radiation therapy may be recommended for primary treatment. Risk stratification of lung cancer patients for surgery is an important preoperative physiological assessment, taking into account cardiovascular health, pulmonary function, comorbidities and predicted postoperative lung function.
Patients with predicted postoperative forced expiratory volume in 1 second (ppoFEV1) or predicted postoperative diffusing capacity for carbon monoxide (ppoDLCO) of less than 40% of predicted normal values have significantly increased risk of perioperative complications or death. Due to the possibility of postoperative respiratory failure, these patients and are often excluded from surgical resection.
Prediction of postoperative lung function is currently based on anatomical segment counting (ASC), which incorporates pulmonary function test (PFT) results. Standard PFTs such as spirometry can only measure pulmonary capacity as an average over the entire lung and do not take regional function differences into account. The predictive validity of the ASC method is less accurate for patients with physiologically compromised lungs such as those with chronic obstructive pulmonary disease (COPD), which is highly prevalent in the NSCLC population. Moreover, as pulmonary function deficit is most likely to be concentrated in the region of the tumour, the ASC method may underestimate post-operative lung function, leading to some patients being wrongly ruled out from receiving surgical treatment.
Nuclear medicine is recommended where regional functional imaging is required to inform surgical decisions. However, nuclear medicine scans are expensive, time consuming and not available in all institutions. CT-ventilation imaging is a cheaper and more accessible alternative to nuclear medicine for informing lung cancer patient treatment choices.
Introduction to CT ventilation imaging CT Ventilation imaging is a novel software-based solution for generating lung function (ventilation) maps from respiratory correlated CT scans, such as breath hold CT (BHCT), where the patient holds their breath for the duration of the scan.
The key steps in CT ventilation imaging are:
- Acquire CT images of the lung at exhale and inhale states, using breath hold CT (BHCT). In BHCT, static end-inspiration and end-expiration images of the lung are acquired as the patient holds their breath for around 10 seconds.
- Deformable image registration is used to determine a spatial mapping (deformation map) between the different CT images (from peak inhale to peak exhale).
- Application of a ventilation metric to quantify high and low functioning lungs which involve quantitative analysis based on the information from the deformable image registration.
The resulting ventilation image is superimposed directly onto the anatomic image, providing an added dimension of functional information which is easy to understand and can be of direct benefit in surgery interventions.
Use of CT Ventilation imaging in assessing lung function for surgery CT Ventilation imaging has been proposed to improve predicted estimates of post-operative lung function by providing regional information on lung function. A preliminary study carried out at Royal North Shore Hospital testing the feasibility of CT Ventilation imaging as a decision tool for marginally resectable patients concluded that lung function derived by CT ventilation imaging correlates strongly with the gold standard PET ventilation on a lobar level.
CT perfusion imaging Lung perfusion imaging is commonly performed together with SPECT ventilation imaging by injecting 99mTc labelled macroaggregated albumen. Following the success of CT based ventilation imaging technique, a new emerging research area is focusing on the development of novel algorithms to assess the blood flow information from the acquired CT images. These modalities will enable us to derive both ventilation and perfusion information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A pilot study is not a hypothesis testing study. Although this design has patients being their own control, the small sample size of 15 patients is unlikely to capture the full diversity of the population. Therefore, the statistical tests are for hypothesis generation and not definitive.
Key inclusion criteria (8 listed)
- Aged 18 years or older.
- ECOG performance status 0-2.
- Lung cancer surgical candidates.
- Undergo SPECT V/Q scans within 8 weeks of registration.
- Undergo BHCT scans within 8 weeks of registration.
Key exclusion criteria (2 listed)
- Interstitial lung disease.
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The accuracy of CT ventilation imaging compared to ASC in predicting postoperative values of the pulmonary function metric FEV1
Time frame: 1 week
The accuracy of CT ventilation imaging compared to ASC in predicting postoperative values of the pulmonary function metric FEV1 will be assessed via a comparison with actual postoperative values measured from PFTs. CT ventilation images will be used to produce regionally-informed ppoFEV1 by proportionally reducing the pre-surgery FEV1 by the proportion of ventilation lost by removal of the surgical target section of lung. As this is an investigative study, it is not powered for a statistical analysis. Bland-Altman analysis will be used to quantify the ability of ASC and CT ventilation to predict ppoFEV1
3 secondary outcomes
The accuracy of CT ventilation imaging in predicting ppoFEV1
Time frame: 1 week
The regional pattern of ventilation from CT ventilation imaging will be compared to ventilation from SPECT using Spearman correlation.
Time frame: 1 week
The regional pattern of perfusion from CT perfusion imaging will be compared to perfusion from SPECT using Spearman correlation.
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Yes. De-identified patient images and demographic data will be shared to a public repository for future research.
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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.
Dasantha Jayamanne, Dr principal investigator
University of Sydney
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 Cancer, run by University of Sydney at 1 site in Australia.
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 8 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 20 May 2026. 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 Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Coordinator (+61 2 8627 1185, shona.silvester@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of CT ventilation imaging compared to ASC in predicting postoperative values of the pulmonary function metric FEV1 (time frame: 1 week). 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 20 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.