Respiratory Adaptive Computed Tomography: Feasibility Study on Real-Time Gated 4DCT for Lung Cancer Radiotherapy

NCT05030207 | Recruiting

• 1 other identifier: REACT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study does not involve a therapeutic intervention as standard radiation therapy treatment will be prescribed. This study involves one additional 4DCT scan (i.e. the Real-Time Gated 4DCT scan) acquired immediately before or following the conventional 4DCT scan. This will take place on the day of the patient's treatment simulation, as per the current standard of care. The scanning sequence (i.e. conventional first versus gated first) will be randomised. The Real-Time Gated 4DCT is anticipated to take longer than the conventional 4DCT scan, due to its gated (beam-pause) nature. However, upper limits for timing will be implemented in the software, and the scan aborted for highly erratic breathing traces that would not benefit from a Real-Time Gated 4DCT scan.

Conditions

Lung Cancer

Keywords

Radiotherapy; 4DCT; Real-time gated 4DCT; Imaging artifacts; Computed tomography

Outcome Measures

Primary Outcomes (1)

• The feasibility of using Real-Time Gated 4DCT instead of Conventional 4DCT for planning radiotherapy for lung cancer.

  A change in the anticipated rate of image artifacts in images acquired from Conventional of 60% to 35% or less in images acquired from Real-Time Gated 4DCT.

  30 minutes

Secondary Outcomes (6)

• Patient tolerance to the experimental scan (Real-Time Gated 4DCT)

  1 minute at end of planning session

• clinician confidence in acquiring a Real-Time Gated 4DCT scan

  5 minutes at end of planning session

• clinician confidence in delineation on a Real-Time Gated 4DCT scan

  5-10 minutes, following delineation of standard care and study scans.

• Effect on Real-Time Gated 4DCT image quality of patient characteristics: breathing type, breathing period, BMI, tumour location, breathing amplitude, breathing regularity, pulmonary function, ECOG status.

  40 minutes, prior to and during the planning session

• Difference in scanning time between Real-Time Gated 4DCT compared with Conventional 4DCT for planning of radiotherapy for lung cancer

  30 minutes

Study Arms (1)

Real-Time Gated 4DCT and Conventional 4DCT

EXPERIMENTAL

During the simulation (radiotherapy planning) session, the participant will undergo both the experimental 'Real-Time Gated 4DCT' and standard 'Conventional 4DCT'.

Diagnostic Test: Real-time Gated 4DCT; Diagnostic Test: Conventional 4DCT

Interventions

Real-time Gated 4DCT DIAGNOSTIC_TEST

Real-time gated four-dimensional cone beam computed tomography (4DCT) will be conducted at the simulation session. The Real-Time Gated 4DCT will be conducted while the patient moves through the rotating X-ray imager. This method detects and then pauses the CT beam during irregular breathing events.

Real-Time Gated 4DCT and Conventional 4DCT

Conventional 4DCT DIAGNOSTIC_TEST

Four-dimensional computed tomography (4DCT), the standard of care for modern high-precision stereotactic ablative body radiotherapy (SABR), will be conducted at the simulation session. It will run continuously while the patient moves through the rotating X-ray imager.

Real-Time Gated 4DCT and Conventional 4DCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Have the ability to give informed consent
• A diagnosis of lung cancer with an indication for radiation therapy
• Radiation therapy treatment involving the acquisition of a 4DCT scan for treatment planning

You may not qualify if:

• Pregnant women
• Patients \<18 years
• Patients who in the opinion of the treating physician could not tolerate the extra time on the CT couch for an extra scan

Sponsors & Collaborators

• University of Sydney: lead
• Western Sydney Local Health District: collaborator

Study Sites (1)

Blacktown Hospital

Blacktown, New South Wales, 2148, Australia

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ricky O'Brien, PhD

  University of Sydney

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shona J Silvester, MMedSc

CONTACT

+61286271185; Shona.Silvester@sydney.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single site, 1 arm unblinded, pilot feasibility clinical trial to investigate the feasibility of acquiring Real-Time Gated 4DCT scans for lung cancer patients undergoing radiation therapy and to determine the incidence of imaging artifacts in comparison to conventional 4DCT

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: September 1, 2021
• Study Start: May 15, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

AU (1)