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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT05030207




Registration number
NCT05030207
Ethics application status
Date submitted
24/06/2021
Date registered
1/09/2021
Date last updated
10/09/2021

Titles & IDs
Public title
Respiratory Adaptive Computed Tomography: Feasibility Study on Real-Time Gated 4DCT for Lung Cancer Radiotherapy
Scientific title
Respiratory Adaptive Computed Tomography: A Pilot Feasibility Study on the Use of Real-Time Gated 4DCT for Lung Cancer Radiation Therapy
Secondary ID [1] 0 0
REACT
Universal Trial Number (UTN)
Trial acronym
REACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Real-time Gated 4DCBCT
Diagnosis / Prognosis - Conventional 4DCBCT

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


Diagnosis / Prognosis: Real-time Gated 4DCBCT
Real-time gated four-dimensional cone beam computed tomography (4DCBCT) 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.

Diagnosis / Prognosis: Conventional 4DCBCT
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.

Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
30 minutes
Secondary outcome [1] 0 0
Patient tolerance to the experimental scan (Real-Time Gated 4DCT) - The radiation therapist conducting the RT study scan will complete a survey consisting of two yes/no qustions 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.)
Timepoint [1] 0 0
1 minute at end of planning session
Secondary outcome [2] 0 0
clinician confidence in acquiring a Real-Time Gated 4DCT scan - The radiation therapist conducting the RT 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.
Timepoint [2] 0 0
5 minutes at end of planning session
Secondary outcome [3] 0 0
clinician confidence in delineation on a Real-Time Gated 4DCT scan - The radiation oncologist performing the delineation on the RT 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.
Timepoint [3] 0 0
5-10 minutes, following delineation of standard care and study scans.
Secondary outcome [4] 0 0
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. - 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).
Timepoint [4] 0 0
40 minutes, prior to and during the planning session
Secondary outcome [5] 0 0
Difference in scanning time between Real-Time Gated 4DCT compared with Conventional 4DCT for planning of radiotherapy for lung cancer - Time in minutes from start to end of scan.
Timepoint [5] 0 0
30 minutes
Secondary outcome [6] 0 0
Quality of treatment plan using images acquired during Real-Time Gated 4DCT compared with images acquired during Conventional 4DCT - 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.
Timepoint [6] 0 0
1 week

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 0 0
2148 - Blacktown

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Western Sydney Local Health District
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT05030207
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ricky O'Brien, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shona J Silvester, MMedSc
Address 0 0
Country 0 0
Phone 0 0
+61286271185
Fax 0 0
Email 0 0
Shona.Silvester@sydney.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT05030207