Actively Recruiting
Ventilation Using Radiographic Examination: Functional Lung Imaging Techniques for the Reduction of Toxicity in Functional Avoidance Radiation Therapy
Led by University of Sydney · Updated on 2026-05-19
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Sydney
Lead Sponsor
N
National Health and Medical Research Council, Australia
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research evaluates different functional lung imaging techniques to improve radiation therapy planning for stages II-IV non-small cell lung cancer. It aims to identify the best use of fluoroscopic and CT ventilation imaging methods, assess dosimetric differences in treatment plans, establish quality assurance procedures, and determine clinically acceptable accuracy thresholds. The study builds on evidence that preserving healthy lung tissue during radiation may reduce side effects like radiation pneumonitis, a common and serious inflammation of lung tissue after treatment. Participants undergo multiple imaging scans before radiotherapy, including standard 4DCT, pulmonary function tests, breath hold CT scans, nuclear medicine scans (Galligas PET and Tc-99m MAA SPECT), fluoroscopy at different chest angles, and 4D cone beam CT. These scans are repeated at treatment end to compare new imaging methods against established ones. The study does not change usual patient care; all receive standard radiation treatment while the new imaging techniques are evaluated. During the study, participants provide data through imaging and lung function tests, allowing researchers to compare ventilation and perfusion images from various methods. The primary measure is the physiological accuracy of X-ray-based ventilation imaging within a week of scanning. Secondary measures include differences in radiation dose to functioning lung, predicted reductions in radiation pneumonitis risk, workflow impact, and improvements in image reconstruction. Follow-up continues for up to one year or until death to monitor ventilation changes and validate imaging accuracy.
CONDITIONS
Brief Title
Ventilation Using Radiographic Examination: Functional Lung Imaging Techniques for the Reduction of Toxicity in Functional Avoidance Radiation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Histologically proven Stage II-IV non-small cell lung cancer as determined using IASLC 8th edition lung cancer staging.
- Planned treatment with non-SABR external beam radiotherapy with curative or palliative intent.
- Pulmonary function tests within 8 weeks of registration.
- 4DCT simulation for radiation therapy.
- Willingness to give written informed consent.
- Willingness and ability to comply with study procedures and visits.
- Available for follow-up for 1 year or until death, whichever occurs first.
You will not qualify if you...
- Prior radiation therapy to the thorax.
- Prior surgery for this cancer.
- Prior chemotherapy for this cancer.
- Interstitial lung disease.
- Pregnant women.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants undergo multiple imaging procedures including Galligas PET ventilation, Tc-99m MAA SPECT perfusion, BHCT, fluoroscopy, 4DCBCT, 4DCT, and 4D PET scans to assess lung function and ventilation for comparison and validation purposes.
Multiple imaging visits within 1 week
Duration - 1 to 2 weeks
Functional based radiotherapy plans are created using ventilation and perfusion imaging data and compared to standard anatomical-based plans to evaluate dosimetric differences and predicted risk reductions for radiation pneumonitis.
1 to 2 planning visits
Duration - 8 weeks
Participants are monitored for changes in lung ventilation following radiation therapy to assess treatment impact and physiological accuracy of imaging techniques over time.
Follow-up visits during 8 weeks
Trial Site Locations
Total: 1 location
1
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
Research Team
C
Clinical Trial Coordinator
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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