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临床试验/NCT06494254
NCT06494254招募中不适用

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

University of Sydney1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
1
主要终点
The accuracy of CT ventilation imaging compared to ASC in predicting postoperative values of the pulmonary function metric FEV1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged 18 years or older.
  • •ECOG performance status 0-
  • •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.

排除标准

  • •Interstitial lung disease.
  • •Pregnant women.

结局指标

主要结局

The accuracy of CT ventilation imaging compared to ASC in predicting postoperative values of the pulmonary function metric FEV1

时间窗: 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

次要结局

  • The regional pattern of perfusion from CT perfusion imaging will be compared to perfusion from SPECT using Spearman correlation.(1 week)
  • The regional pattern of ventilation from CT ventilation imaging will be compared to ventilation from SPECT using Spearman correlation.(1 week)
  • The accuracy of CT ventilation imaging in predicting ppoFEV1(1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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