RecruitingNot Applicable

Ventilation Using Radiographic Examination: Functional Lung Imaging Techniques for the Reduction of Toxicity in Functional Avoidance Radiation Therapy

Australia15 participantsStarted 2025-02-17

Plain-language summary

The goal of this observational validation study is to determine the best implementation of fluoroscopic and CT ventilation imaging in patients having non-stereotactic ablative body radiotherapy (non-SABR) radiotherapy for stages II-IV lung cancer. The main questions it aims to answer are: * Assess the dosimetric variation in functional avoidance radiation therapy (RT) plans produced using these ventilation imaging techniques, * Establish a quality assurance procedure for functional lung avoidance radiation therapy, and * Evaluate the clinical acceptable thresholds for accuracy of the method. Participants will: Prior to radiation therapy treatment, patients will undergo: 1. A standard of care 4DCT scan for radiation therapy simulation, 2. Pulmonary Function Tests (PFT) 3. A 4D attenuation correction CT 4. Breath Hold Computed Tomography (BHCT) imaging where static end-inspiration and end-expiration BHCT scans will be acquired, 5. Nuclear medicine imaging where a Tc-99m MAA SPECT perfusion scan and a Galligas PET ventilation scan will be acquired, 6. Fluoroscopy where 1-breath cine-fluoroscope sequences will be acquired at five different angles across the chest, 7. A 4D Cone Beam Computed Tomography (4DCBCT) scan. 8. Scans in points 4 to 7 above will be repeated at the end of treatment. Individual participants provide their own internal control. Galligas PET ventilation images (control) are compared with ventilation images derived from additional scans (comparator) for each participant. Tc-99m MAA SPECT perfusion images (control) are compared with perfusion images derived from BHCT scans (comparator) for each patient. There will be no change to patient treatment and patients will be treated using a standard of care anatomical based treatment plan. The pre-treatment 4DCBCT scan is part of standard of care.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 the IASLC International Association for the Study of Lung Cancer (IASLC) 8th edition lung cancer staging guidelines. * To be treated with curative intent (stage II-III) or palliative intent (stage IV) with non-SABR external beam radiotherapy (e.g. 60 Gy in 30 treatments for curative intent or 30 Gy in 5 treatments for 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 the study procedures and visit requirements. * Available for follow up for 1 year or until death, whichever occurs first. Exclusion Criteria: * Prior radiation therapy to the thorax. * Prior surgery for this cancer. * Prior chemotherapy for this cancer. * Interstitial lung disease. * Pregnant women.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Physiological accuracy of X-ray-based ventilation imaging (BHCT, fluoroscopy, 4DCBCT, 4DCT)

Timeframe: 1 week

Trial details

NCT IDNCT06159660

SponsorUniversity of Sydney

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09-01

Contact for this trial

Clinical Trial Coordinator

+61 2 8627 1185 Shona.Silvester@sydney.edu.au

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