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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05030207
Recruitment Status : Not yet recruiting
First Posted : September 1, 2021
Last Update Posted : October 20, 2021
Western Sydney Local Health District
Information provided by (Responsible Party):
University of Sydney

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Diagnostic Test: Real-time Gated 4DCT Diagnostic Test: Conventional 4DCT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Respiratory Adaptive Computed Tomography: A Pilot Feasibility Study on the Use of Real-Time Gated 4DCT for Lung Cancer Radiation Therapy
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

Arm Intervention/treatment
Experimental: Real-Time Gated 4DCT and Conventional 4DCT
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
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.

Diagnostic Test: Conventional 4DCT
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.

Primary Outcome Measures :
  1. The feasibility of using Real-Time Gated 4DCT instead of Conventional 4DCT for planning radiotherapy for lung cancer. [ Time Frame: 30 minutes ]
    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.

Secondary Outcome Measures :
  1. Patient tolerance to the experimental scan (Real-Time Gated 4DCT) [ Time Frame: 1 minute at end of planning session ]
    The radiation therapist conducting the radiation therapy study scan will complete a survey consisting of two yes/no questions after the planning session to assess patient tolerance (1. whether the patient finishes the scan without getting off the couch. 2. If the patient voiced any complaints during the scan and seem uncomfortable.)

  2. clinician confidence in acquiring a Real-Time Gated 4DCT scan [ Time Frame: 5 minutes at end of planning session ]
    The radiation therapist conducting the radiation therapy study scan will complete an in-house survey of 10 questions after the treatment session to evaluate their experience with REACT software and its usability.

  3. clinician confidence in delineation on a Real-Time Gated 4DCT scan [ Time Frame: 5-10 minutes, following delineation of standard care and study scans. ]
    The radiation oncologist performing the delineation on the radiation therapy planning scan images and study scan images will complete an in-house survey of 10 questions to evaluate his experience with REACT and his confidence with using REACT for delineation.

  4. 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. [ Time Frame: 40 minutes, prior to and during the planning session ]
    Correlation between image quality (the number of artifacts greater than 4mm in the images acquired from Real-Time Gated 4DCT) and participant characteristics known to affect image quality in conventional scans: Breathing period ( seconds) and breathing amplitude will be measured using the Varian real-time position management system; body mass index (weight(kg) x height(m)2); tumour location;, breathing regularity (root mean square error (RMSE) of 6 breaths/min was obtained), pulmonary function, Performance status (Eastern Cooperative Oncology Group (ECOG) performance scale).

  5. Difference in scanning time between Real-Time Gated 4DCT compared with Conventional 4DCT for planning of radiotherapy for lung cancer [ Time Frame: 30 minutes ]
    Time in minutes from start to end of scan.

  6. Quality of treatment plan using images acquired during Real-Time Gated 4DCT compared with images acquired during Conventional 4DCT [ Time Frame: 1 week ]
    Contouring and planning using the Real-Time Gated 4DCT image set to develop a treatment plan of prescribed radiation therapy. Treatment plans will be assessed using the 3%/3mm and 2%/2mm gamma pass index.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05030207

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Contact: Shona J Silvester, MMedSc +61286271185
Contact: Natalie A Plant, MHSc +61286271133

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Australia, New South Wales
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
Sponsors and Collaborators
University of Sydney
Western Sydney Local Health District
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Principal Investigator: Ricky O'Brien, PhD University of Sydney
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Responsible Party: University of Sydney Identifier: NCT05030207    
Other Study ID Numbers: REACT
First Posted: September 1, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sydney:
Real-time gated 4DCT
Imaging artifacts
Computed tomography
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases