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Clinical Trials in Australia / NCT06494254
Recruiting Observational

Post-Operative Prediction of PulmonarY Function

NCT06494254 · tracked via the Priya Life Science Australia tracker
Sponsor
University of Sydney
Phase
Observational
Started
2025-06-25
Last updated
2026-05-20

Condition(s) studied

Lung Cancer

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Interstitial lung disease. * Pregnant women.

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Royal North Shore Hospital Saint Leonards New South Wales Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06494254 on ClinicalTrials.gov ↗ ← All trials in Australia