Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494254
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Post-Operative Prediction of PulmonarY Function
Sponsor:
University of Sydney
Organization:
University of Sydney
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POPPY
Brief 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 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
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
1 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
2 Deformable image registration is used to determine a spatial mapping deformation map between the different CT images from peak inhale to peak exhale
3 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
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
1 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
2 Deformable image registration is used to determine a spatial mapping deformation map between the different CT images from peak inhale to peak exhale
3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None