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

Recruiting now

Conditions studied: Lung Neoplasm

In brief

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.

Key facts

Study ID

NCT06159660

Run by

University of Sydney

People needed

15

Starts

2025-02-17

Expected to finish

2026-09-01

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Prior radiation therapy to the thorax.
• Prior surgery for this cancer.
• Prior chemotherapy for this cancer.
• Interstitial lung disease.
• Pregnant women.

Where it is running

• Royal North Shore Hospital — St Leonards, New South Wales, Australia (enrolling)

Full record on ClinicalTrials.gov

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