NCT06159660

Brief 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:
  • A standard of care 4DCT scan for radiation therapy simulation,
  • Pulmonary Function Tests (PFT)
  • A 4D attenuation correction CT
  • Breath Hold Computed Tomography (BHCT) imaging where static end-inspiration and end-expiration BHCT scans will be acquired,
  • Nuclear medicine imaging where a Tc-99m MAA SPECT perfusion scan and a Galligas PET ventilation scan will be acquired,
  • Fluoroscopy where 1-breath cine-fluoroscope sequences will be acquired at five different angles across the chest,
  • A 4D Cone Beam Computed Tomography (4DCBCT) scan.
  • Scans in points 4 to 7 above will be repeated at the end of treatment. Individual participants provide their own internal control.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
3mo left

Started Jul 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jul 2024Sep 2026

First Submitted

Initial submission to the registry

August 22, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

2.2 years

First QC Date

August 22, 2023

Last Update Submit

July 8, 2024

Conditions

Lung Neoplasm

Keywords

CTVIComputed tomography ventilation imagingVentilation imagingRadiation therapyRadiotherapyExternal beamFunctional lung imagingPulmonary fibrosisCTPIComputed tomography perfusion imagingMAAMacroaggregated AlbuminSPECTSingle Photon Emission Computed Tomography

Outcome Measures

Primary Outcomes (1)

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

    Voxel-based Spearman correlation between X-ray-based ventilation imaging and nuclear medicine ventilation images (Galligas PET)

    1 week

Secondary Outcomes (7)

  • Difference in mean dose to high functioning lung structures between avoidance treatment plans and standard of care anatomical based treatment plans.

    1 week

  • Difference in percentage volume of high functioning lung structures receiving 20 Gray (20Gy) or more between functional lung avoidance treatment plans and standard of care anatomical based treatment plans.

    1 week

  • Reduction in predicted risk of grade 2+ radiation pneumonitis (CTCAE v5) in functional lung avoidance treatment plans compared to standard of care anatomical based treatment plans.

    1 week

  • Increased burden in the radiotherapy workflow involved with creating functional lung avoidance treatment plans.

    2 weeks

  • Change in ventilation from lung radiation therapy.

    8 weeks

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients having non-SABR radiotherapy for stage II-IV lung cancer at Northern Sydney Cancer Centre, Sydney Australia.

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.
  • DCT 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

MeSH Terms

Conditions

Lung NeoplasmsPulmonary Fibrosis

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesLung Diseases, InterstitialFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ricky O'Brien

    University of Sydney

    STUDY CHAIR

  • Dasantha Jayamanne

    Northern Sydney Local Health District

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Coordinator

CONTACT

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

Study Design

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

Study Record Dates

First Submitted

August 22, 2023

First Posted

December 7, 2023

Study Start

July 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

After study completion, to maximise the scientific and clinical use of individual participant data (IPD) they will be made available to researchers for further scientific research. It will be stored at the University of Sydney and is likely to also be stored at an external research data repository archive or register, e.g. The Cancer Imaging Archive, and made publicly available. They may also be used in imaging scientific challenges, similar to previously scientific grand challenges we have led such as the SPARE and MATCH challenges.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After study completion and results published, IPD will be available indefinitely.
Access Criteria
IPD stored at the university: To download / decompress IPD, participating researchers will agree to the terms of use for the data, including that the data are not to be published or otherwise redistributed without the express consent of the original investigator(s). IPD stored at an external repository: IPD will be stored at and managed by the external repository. IPD will only be shared with repositories whose function has been reviewed and approved by an accredited Research Integrity/Ethics Committee/Board.

Locations

AU(1)