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

NCT06159660 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

  • Lung Neoplasm

Sponsors & Collaborators

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • Northern Sydney and Central Coast Area Health Service

    collaborator OTHER

  • University of Sydney

    lead OTHER

Principal Investigators

  • Ricky O'Brien · University of Sydney

  • Dasantha Jayamanne · Northern Sydney Local Health District

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-17
Primary Completion
2026-09-01
Completion
2026-09-01

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06159660 on ClinicalTrials.gov