Post-Operative Prediction of PulmonarY Function

NCT06494254 | Recruiting

• 1 other identifier: IX-2023-OV-POPPY
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

ventilation imaging; CT ventilation imaging; lung cancer; lung imaging

Outcome Measures

Primary Outcomes (1)

• 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

  1 week

Secondary Outcomes (3)

• The accuracy of CT ventilation imaging in predicting ppoFEV1

  1 week

• The regional pattern of ventilation from CT ventilation imaging will be compared to ventilation from SPECT using Spearman correlation.

  1 week

• The regional pattern of perfusion from CT perfusion imaging will be compared to perfusion from SPECT using Spearman correlation.

  1 week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Interstitial lung disease.
• Pregnant women.

Sponsors & Collaborators

• University of Sydney: lead
• Royal North Shore Hospital: collaborator

Study Sites (1)

Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dasantha Jayamanne, Dr

  University of Sydney

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Coordinator

CONTACT

+61 2 8627 1185; shona.silvester@sydney.edu.au

Study Manager

CONTACT

+61 2 8627 1185; hunor.kertesz@sydney.edu.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: June 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Following publication of final analysis
• Access Criteria: To be determined

Locations

AU (1)