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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05030207
Ethics application status
Date submitted
24/06/2021
Date registered
1/09/2021
Date last updated
6/06/2024

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 4DCT
Diagnosis / Prognosis - Conventional 4DCT

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'.


Diagnosis / Prognosis: 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.

Diagnosis / Prognosis: 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.
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.
Timepoint [1] 0 0
30 minutes
Secondary outcome [1] 0 0
Patient tolerance to the experimental scan (Real-Time Gated 4DCT)
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
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
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.
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
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
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
Sex
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
Not applicable
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
30
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/study/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
[email protected]
Contact person for scientific queries



Summary Results

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